Antifungal compositions for the treatment of skin and nails

ABSTRACT

The invention concerns a composition and method for treating an ungual infection, the composition comprising an iodophor and dimethylsulfoxide (DMSO).

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a U.S. National Stage Entry of InternationalPatent Application No. PCT/US2012/036942, filed 8 May 2012, which inturn claims priority benefit from US Provisional Patent Application Nos.61/518,709, filed 11 May 2011; 61/600,268, filed 17 Feb. 2012;61/627,148, filed 19 Sep. 2011; 61/518,689, filed 11 May 2011;61/518,690, filed 11 May 2011; and 61/457,699, filed 16 May 2011, all ofwhich are hereby incorporated by reference in their entireties.

BACKGROUND

Onychomycosis—nail fungal infection—affects 30-60 million patients eachyear in the United States. It is the most common disease of the nailsand constitutes about a half of all nail abnormalities. This conditionmay affect toenails or fingernails, but toenail infections areparticularly common. The prevalence of onychomycosis is about 6-8% ofthe United States adult population. Common signs of onychomycosisinclude a thickened, yellow, or cloudy appearance of the nails. Thenails can become rough and crumbly, and can separate from the nail bed.Patients with onychomycosis may experience significant psychosocialproblems due to the appearance of the nail.

The causative pathogens of onychomycosis include dermatophytes, Candida,and nondermatophytic molds. Dermatophytes are the fungi most commonlyresponsible for onychomycosis in the temperate western countries, whileCandida and nondermatophytic molds are more frequently involved in thetropics and subtropics with a hot and humid climate. Trichophyton rubrumis a common dermatophyte involved in onychomycosis. Other dermatophytesthat may be involved are T. mentagrophytes, Epidermophyton floccosum, T.violaceum, Microsporum gypseum, T. tonsurans, T. soudanense and thecattle ringworm fungus T. verrucosum. Other causative pathogens includeCandida and nondermatophytic molds, in particular members of the moldgeneration Scytalidium (now called Neoscytalidium), Scopulariopsis, andAspergillus. Candida spp. are known to cause fingernail onychomycosis inpeople whose hands are often submerged in water. Scytalidium mainlyaffects people in the tropics, though it persists if they later move toareas of temperate climate. Control of these pathogens can be used totreat onychomycosis.

BRIEF SUMMARY

In an embodiment, disclosed herein is a composition for treating anungual infection, the composition comprising an iodophor anddimethylsulfoxide (DMSO), wherein the composition is capable ofpenetrating the unguis to treat the infection.

In an embodiment, disclosed herein is a composition for treating anungual infection, the composition comprising elemental iodine anddimethylsulfoxide (DMSO), wherein the composition is capable ofpenetrating the unguis to treat the infection. In an embodiment, theiodophor is selected from the group consisting of povidone iodine(PVP-I), iodine tincture, Lugol's solution, potassium iodide, and sodiumiodide.

In an embodiment, a composition disclosed herein for treatment of anungual infection is substantially anhydrous. In an embodiment, thecomposition is anhydrous.

In an embodiment, a composition disclosed herein for treatment of anungual infection includes PVP-I at about 0.01% to about 10% (w/w). In anembodiment, PVP-I is present in a range selected from the groupconsisting of about 0.05% to about 10%, about 0.1% to about 5%, about0.2% to about 2.5%, and about 0.5% to about 1% (w/w). In an embodiment,PVP-I is present in a range selected from the group consisting of about0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 1.0%, about1.25%, about 1.5%, about 2.0%, about 2.5%, and about 5% (w/w). In anembodiment, PVP-I is present at about 1% (w/w).

In an embodiment, a composition disclosed herein for treatment of anungual infection further comprises at least one naturopathic substance.In an embodiment, a composition disclosed herein for treatment of anungual infection further comprises at least one substance selected fromthe group consisting of Punica Granatum Extract, Camellia Sinensis LeafExtract, Ascorbic Acid, Calendula Officinalis, Extract, GlycrrhizaGlabra Extract, Allantoin, and Cucumis Sativus Fruit Extract.

In an embodiment, a composition disclosed herein for treatment of anungual infection further comprises at least one antifungal agentselected from the group consisting of tolnaftate, terbinafine,undecylenic acid, clioquinol, miconazole, miconazole nitrate,clorrinazole, tioconazole, nystatin, terconazoic, butoconazole nitrate,ciclopirox olamine, econazole nitrate, triacetin, flucytosine,haloprogin, and ketoconazole. In an embodiment, an antifungal agent ispresent in an amount of about 1% to about 25% (w/w).

In an embodiment, disclosed herein is a composition for treating anungual infection, the composition comprising an iodophor anddimethylsulfoxide (DMSO), wherein the composition is capable ofpenetrating the unguis to treat the infection, further wherein thecomposition does not comprise a polyglycol.

In an embodiment, disclosed herein is a composition for treating anungual infection, the composition comprising an iodophor anddimethylsulfoxide (DMSO), wherein the pharmaceutical composition iscapable of penetrating the unguis to treat the infection.

In an embodiment, the infection treated is a fungal infection. In anembodiment, the infection is a dermatophyte infection.

In an embodiment, disclosed herein is a method for treating an ungualinfection, comprising contacting at least one of an infected nail and anon-ungual tissue adjacent to a nail with a composition disclosedherein, and repeating the contacting step as necessary until the ungualinfection has been treated. In an embodiment, the contacting step isconducted at least once a day. In an embodiment, the contacting step isconducted at least twice a day.

In an embodiment, disclosed herein is a method for treating an ungualinfection, comprising contacting at least one of an infected nail and anon-ungual tissue adjacent to a nail with a composition of claim 1 andrepeating the contacting step for at least four weeks. In an embodiment,the contacting step is repeated for at least 12 weeks.

In an embodiment, disclosed herein is a method for treatingonychomycosis, comprising contacting at least one of an infected nailand a non-ungual tissue adjacent to a nail with a composition of claim1, and repeating the contacting step for at least four weeks.

In an embodiment, disclosed herein is a method for treatingonychomycosis, comprising contacting at least one of an infected nailand a non-ungual tissue adjacent to a nail with a composition of claim3, and repeating the contacting step for at least four weeks.

In an embodiment, disclosed herein is a method for treating an infectionof a nail, comprising contacting at least one of an infected nail and anon-ungual tissue adjacent to a nail with a composition of claim 1, andrepeating the contacting step for at least four weeks, wherein theinfection is caused by at least one of the members selected from thegroup consisting of Trichophyton rubrum, T. mentagrophytes,Epidermophyton floccosum, T. violaceum, Microsporum gypseum, T.tonsurans, T. soudanense, T. verrucosum, and members of Candida spp.,Neoscytalidium spp., Scopulariopsis spp., and Aspergillus spp.

DETAILED DESCRIPTION

Povidone-iodine (PVP-I) is a well known antiseptic to almost everymedical specialty. It has gained recent interest beyond simpledisinfection as a therapy for active infections in the eye, ear,sinuses, articular compartments and skin. There is no known antibiotic,fungal or viral resistance to PVP-I and no known species of yeast orfungus that cannot be eliminated with PVP-I. The development ofresistance, which is inevitable for certain species when using mostconventional antibiotics, is extremely unlikely given the mechanism ofPVP-I antisepsis. PVP-I has also been shown to inhibit the formation ofbiofilms and to eliminate biofilms that have already formed.

A variety of organic solvents are known to enhance the percutaneousabsorption of medicaments, including dimethylsulfoxide (DMSO). Thesuperiority of DMSO to other solvents both in enhancing penetration andin favoring dermal retention was demonstrated in a study of the passageof ¹⁴C-labelled griseofulvin, dissolved in DMSO, dimethylacetamide,dimethylformamide, alcohol or benzene, through human skin in vitro. Theratios of penetration of griseofulvin in the various solvents was 60,40, 7, 3, and 1, respectively. Even when a 50% solution of DMSO in waterwas used, the rate of penetration of ¹⁴C hydrocortisone was markedlyenhanced. It has now been surprisingly discovered, as disclosed herein,that DMSO is effective at enhancing penetration into and through theheavily keratinized nail bed.

DMSO has been shown to enhance the percutaneous penetration of manydrugs. DMSO has also been shown to enhance the rate of penetration ofwater through the skin when the epidermis was treated for 30 minuteswith 60%, 80% and 90% aqueous solutions of DMSO. Many theoriesconcerning the mechanism of action of penetrants have appeared in theliterature. One attributes the penetrant effects of DMSO,dimethylformamide, and dimethylacetamide to their hygroscopic propertieswhich increase the water content of the stratum corneum, thereby greatlyincreasing its permeability. Another attributes the effectiveness ofpenetration enhancers to their ability to lower the barrier propertiesof the stratum corneum by modifying its natural structure. Organicsolvents like benzene, alcohol, and ether, which have been shown toenhance the penetration rate of both water soluble and lipid-solublesubstances, may act by removing the lipids from the stratum corneum.However, the action of hydrogen-bonding solvents like DMSO,dimethylformamide, and dimethylacetamide, for example, is attributed tomembrane expansion and uniform increase in media diffusivity.

In an aspect, as further described herein, it was surprisingly foundthat anhydrous compositions comprising PVP-I and DMSO are effective fortreating ungual fungal infections. This is surprising, in part, becausethe chemistry of PVP-I has heretofore been taught to require aqueousequilibrium. In an embodiment, it is now shown that aprotic anhydrouscompositions comprising PVP-I and DMSO can behave antiseptically in avery similar fashion to aqueous PVP-I compositions. In another aspect,as further described herein, it was surprisingly found thatsubstantially anhydrous compositions comprising PVP-I and DMSO, as wellas compositions comprising PVP-I and DMSO comprising less than 10% water(w/w), are effective for treating ungual fungal infections.

In another aspect, as further described herein, is was surprisinglyfound that the compositions and methods encompassed herein are usefulfor treating conditions in addition to ungual fungal infections,including, but not limited to, other fungal infections, yeastinfections, viral infections, and bacterial infections, including bothgram positive and gram negative bacteria. In an aspect, as furtherdescribed herein, it was surprisingly found that the compositions andmethods encompassed herein are useful for treating paronychia.

Contemplated herein are compositions comprising at least one penetrantand at least one active agent for the treatment of ungual fungalinfections, and methods of using the same. In an embodiment, disclosedherein are compositions comprising DMSO and PVP-I. Also disclosed hereinare methods of using compositions comprising DMSO and PVP-I.

Therapeutic Indications

In an embodiment, disclosed herein are compositions and methods fortreating onychomycosis, or nail (ungual) fungal infection. Therefore,the compositions and methods are useful for treatment of the unguis, orungual surfaces, areas adjacent to or contact the unguis, or areasnearby an ungual surface. In an embodiment, the compositions and methodsherein treat infections located in one or more of the unguis, thesubungual space, and the periungual space. The compositions and methodsare further useful in treating any combination of the above.

The term “treating”, as used herein, refers to a detectable improvementin an adverse condition and/or a lessening the symptoms of the conditionupon contacting a mammal with a composition disclosed or encompassed bythe disclosure herein. The term “treating” encompasses both a partialimprovement in an adverse condition and a complete eradication (i.e.,“cure”) of the condition. In an aspect, an infection is treated.

The compositions and methods are useful for treatment of infectionsinvolving, but not limited to, dermatophytes, Candida, andnondermatophytic molds. The compositions and methods are useful fortreating infections involving Trichophyton rubrum, T. mentagrophytes,Epidermophyton floccosum, T. violaceum, Microsporum gypseum, T.tonsurans, T. soudanense, T. verrucosum, as well as Neoscytalidium,Scopulariopsis, and Aspergillus.

The compositions can also be used to treat virtually any kind of fungaland/or mycotic pathogens (some of which are described in Scrip'sAntifungal Report (1992)) responsible for a variety of diseases inhumans, ranging from mycoses involving unguis, skin, hair, or mucousmembranes, further including, but not limited to, Absidia spp.,Actinomadura madurae, Actinomyces spp., Allescheria boydii, Alternariaspp., Anthopsis deltoidea, Apophysomyces elegans, Arnium leoporinum,Aspergillus spp., Aureobasidiun pullulans, Basidiobolus ranarum,Bipolaris spp., Blastomyces dermatitidis, Candida spp., Cephalosporiumspp., Chaetoconidium spp., Chaetomium spp., Cladosporium spp.,Coccidioides immitis, Conidiobolus spp., Corynebacterium tenuis,Cryptococcus spp., Cunninghamella bertholletiae, Curvularia spp.,Dactylaria spp., Epidermophyton spp., Epidermophyton floccosum,Exserophilum spp., Exophiala spp., Fonsecaea spp., Fusarium spp.,Geotrichum spp., Helminthosporium spp., Histoplasma spp., Lecythophoraspp., Madurella spp., Malassezia furfur, Microsporum spp., Mucor spp.,Mycocentrospora acerina, Nocardia spp., Paracoccidioides brasiliensis,Penicillium spp., Phaeosclera dematioides, Phaeoannellomyces spp.,Phialemonium obovatum, Phialophora spp., Phoma spp., Piedraia hortai,Pneumocystis carinii, Pythium insidiosum, Rhinocladiella aquaspersa,Rhizomucor pusillus, Rhizopus spp., Saksenaea vasiformis, Sarcinomycesphaeomuriformis, Sporothrix schenckii, Syncephalastirum racemosuin,Taeniolella boppii, Torulopsosis spp., Trichophyton spp., Trichosporonspp., Ulocladium chartarum, Wangiella dermatitidis, Xylohypha spp.,Zygomyetes spp., Tinea barbae, Tinea capitis, Tinea corporis, Tineacruris, Tinea favosa, Tinea imbricata, Tinea manuum, Tinea nigra(palmalis), Tinea pedis, Tinea unguium, Torulopsosis, Trichomycosisaxillaris, White piedra. Such organisms are responsible for conditionsand infections such as, but not limited to Otitis externa (otomycosis),Actinomycosis, Aspergillosis, Candidiasis, Chromomycosis,Coccidioidomycosis, Cryptococcosis, Entomophthoramycosis, Geotrichosis,Histoplasmosis, Mucormycosis, Mycetoma, Nocardiosis, North AmericanBlastomycosis, Paracoccidioidomycosis, Phaeohyphomycosis, Phycomycosis,pneumocystic pneumonia, Pythiosis, Sporotrichosis, and Torulopsosis.Other fungi that have pathogenic potential include, but are not limitedto, Thermomucor indicae-seudaticae, Radiomyces spp., and other speciesof known pathogenic genera. These fungal organisms are ubiquitous inair, soil, food, decaying food, etc.

The compositions and methods encompassed herein may also have anti-viraland/or anti-bacterial properties. In an embodiment, treatment of apatient using the compositions and methods encompassed herein may alsotreat a viral and/or bacterial infection as a fungal or mycoticinfection is being treated in a patient. In an embodiment, treatment ofa patient using the compositions and methods encompassed herein may bedeliberately used to treat a viral and/or bacterial infection in apatient, apart from treatment of a fungal or mycotic infection in apatient. In an embodiment, the compositions and methods encompassedherein can be used to treat paronychia. Paronychia is an infection ofthe soft tissue surrounding the unguis, and may be associated with anungual infection. Paronychia may involve infections of one or more offungal, bacterial, and yeast origins. In an embodiment, compositionsand/or methods encompassed herein are also useful for treating one ormore of—but not limited to—verrucous warts, molluscum contagiosum,non-genital herpes simplex, scars, gram negative toe-web infection,psoriatic nail dystrophy, and tinea pedis.

The compositions and methods are useful in treating one or anycombination of at least two of the above diseases, conditions orpathogens.

Compositions

In an embodiment, a composition comprises at least one therapeutic agentand at least one solvent and/or penetrant. In an aspect, an iodophor isa therapeutic agent. In an embodiment, a composition comprises at leastone antiseptic compound. In an aspect, an antiseptic compound is atherapeutic agent. In an embodiment, a composition comprises an iodophorantiseptic. “Iodophor”, as used herein, refers to a substance comprisingiodine and at least one additional agent (e.g., a solubilizing agent)that releases free iodine when in solution. Examples of iodophorsinclude, but are not limited to, povidone iodine (PVP-I), iodinetincture, Lugol's solutions, and iodine salts (e.g., potassium iodide,sodium iodide).

In an embodiment, a composition comprises at least one iodophor. Thecompositions encompass any iodophor, as well as iodophors as yet to bedeveloped or discovered. In an embodiment, the iodophor is PVP-I. Inanother embodiment, a composition comprises iodine. In an embodiment, acomposition comprises iodine and at least one iodophor.

In an embodiment, PVP-I functions a therapeutic agent in a composition.In an aspect, a PVP-I therapeutic agent functions as an antiseptic. Inanother embodiment, PVP-I functions as a preservative in a composition.In an aspect, a PVP-I preservative functions as an antiseptic. Inanother aspect, a PVP-I preservative functions as a stabilizer. In anembodiment, PVP-I functions in at least once capacity in a composition.In another embodiment, PVP-I functions in at least two capacities in acomposition.

In another embodiment, a composition further comprises at least onenon-iodophor, non-iodine therapeutic agent. In an embodiment, the atleast one non-iodophor, non-iodine therapeutic agent is an antiseptic.In another embodiment, the at least one non-iodophor, non-iodinetherapeutic agent is not an antiseptic.

In an embodiment, the at least one non-iodophor, non-iodine therapeuticagent is an antifungal agent. Suitable antifungal agents include, forexample, allylamines and azoles. In an embodiment, an antifungal agentincludes, but is not limited to, tolnaftate, terbinafine, undecylenicacid, clioquinol, miconazole, miconazole nitrate, clorrinazole,tioconazole, nystatin, terconazoic, butoconazole nitrate, ciclopiroxolamine, econazole nitrate, triacetin, flucytosine, haloprogin, andketoconazole.

In an embodiment, a composition comprises one or more naturopathicsubstances. Naturopathic substances include, but are not limited to,Punica Granatum (Pomegranate) Extract, Camellia Sinensis Leaf (GreenTea) Extract, Ascorbic Acid (Vitamin-C), Calendula Officinalis Extract,Glycrrhiza Glabra (Licorice) Extract, Allantoin, and Cucumis Sativus(Cucumber) Fruit Extract. In an embodiment, a composition comprisesDMSO, PVP-I, Punica Granatum (Pomegranate) Extract, Camellia SinensisLeaf (Green Tea) Extract, Ascorbic Acid (Vitamin-C), CalendulaOfficinalis Extract, Glycrrhiza Glabra (Licorice) Extract, Allantoin,and Cucumis Sativus (Cucumber) Fruit Extract.

In an embodiment, a composition comprises at least one solvent and/orpenetrant. In an embodiment, a single component may function as both asolvent and a penetrant in the composition. In an embodiment, acomposition comprises DMSO. In an aspect, DMSO functions as a penetrantfor the active component. In an aspect, DMSO functions as a solvent. Inyet another aspect, DMSO functions as both a solvent and a penetrant. Inan embodiment, DMSO is the sole penetrant in a composition. In anembodiment, DMSO is the sole solvent in a composition. In an embodiment,DMSO is the sole penetrant and solvent in a composition.

In an embodiment, a composition comprises PVP-I and DMSO. In anotherembodiment, a composition consists of PVP-I and DMSO. In yet anotherembodiment, a composition consists essentially of PVP-I and DMSO.

One of skill in the art will understand, based on the disclosure herein,how to identify a penetrant useful for the compositions and methodsencompassed herein. In an embodiment, a penetrant is one which is usefulfor enabling the composition to penetrate the unguis. By way of anon-limiting example, methylsulfonylmethane may be used as a penetrantin a composition as encompassed herein.

In an embodiment, a composition comprises at least one co-solvent. In anembodiment, a composition comprises DMSO as a primary solvent, andfurther comprises at least one co-solvent. In an embodiment, water is aco-solvent. In an embodiment, a composition comprises DMSO as theprimary solvent and water as a co-solvent. In an embodiment, acomposition consists of DMSO as the primary solvent and water as theco-solvent. In another embodiment, a composition consists essentially ofDMSO as the primary solvent and water as the co-solvent. In anembodiment, a composition comprises at least one co-solvent such as, butnot limited to, water, or ethanol. In an embodiment, a co-solvent is oneor more polar aprotic solvent. In an embodiment, a co-solvent is ethylacetate. In an embodiment, a co-solvent is at least one of ethylacetate, acetone, acetonitrile, tetrahydrofuran, methylene chloride, anddimethyl formamide. One of skill in the art will understand theadvantages and limitations of the use of co-solvents, based on theproperties and physical effects of such potential co-solvents, in viewof the disclosure set forth herein.

In an embodiment, a composition comprises at least one excipient suchas, but not limited to, sodium chloride, sodium dihydrogen phosphatemonohydrate, disodium hydrogen phosphate anhydrous and water. Thecompositions encompassed herein will be understood to optionally includeone or more other excipients as known to those skilled in the art. Oneof skill in the art will know how to identify such an excipient asuseful in the present compositions and methods, for example, when suchan excipient enhances the therapeutic effectiveness, stability, orpotency of a composition or method.

Dosages, Forms and Formulations

In an embodiment, a composition comprises a therapeutically effectiveamount of at least one therapeutic agent. The term “therapeuticallyeffective amount” is used herein, unless otherwise indicated, todescribe an amount of a compound which, in context, is used to produceor effect an intended therapeutic result. In an embodiment, the intendedtherapeutic result relates to the treatment of onychomycosis. In anembodiment, a therapeutically effective amount is that amount which issufficient to treat an ungual infection, and the treatment of the ungualinfection includes at least one of preventing or slowing the progressionof the infection, preventing the spread of the infection, eradicating atleast some of the infection, and eradicating the entire infection. In anaspect, a therapeutically effective amount may be determined based on asingle dosage or it may be determined based on multiple dosages of thecomposition. It will be understood that determination of thetherapeutically effective amount may require trial and error, and mayrequire adjustment of the dosage and or dosing regimen. Such therapeuticoptimization and adjustment is encompassed by the methods encompassedherein.

The term “pharmaceutically acceptable”, as used herein with respect to acompound or composition, refers to a form of the compound or compositionthat can increase or enhance the solubility or availability of thecompound in a subject, in order to promote or enhance thebioavailability of the compound or composition. In an aspect, thedisclosure herein also encompasses pharmaceutically acceptable,hydrates, solvates, stereoisomers, or amorphous solids of the compoundsand compositions embodied herein.

As used herein, “pharmaceutically acceptable carrier” includes any andall solvents, dispersion media, coatings, surfactants, antioxidants,preservatives (e.g., antibacterial agents, antifungal agents), isotonicagents, absorption delaying agents, salts, preservatives, drugs, drugstabilizers, gels, binders, excipients, disintegration agents,lubricants, sweetening agents, flavoring agents, dyes, such likematerials and combinations thereof, as would be known to one of ordinaryskill in the art (see, for example, Remington's Pharmaceutical Sciences,1990, incorporated herein by reference). Except insofar as anyconventional carrier is incompatible with the active ingredient ormethod of use, its use in the pharmaceutical compositions iscontemplated.

Percentages set forth herein are (w/w), with respect to the specifiedcomponent in the overall composition, unless otherwise indicated. Forexample, a composition comprising 1% PVPI and 99% DMSO has 1% PVP-I byweight, with respect to the total composition.

In an embodiment, a composition comprises an iodophor in the range ofabout 0.01% to about 15%. In another embodiment, a composition comprisesan iodophor in the range between 0.05% and 12.5%. In another embodiment,a composition comprises an iodophor in the range between 0.05% and10.0%. In another embodiment, a composition comprises an iodophor in therange between 0.1% and 10.0%. In another embodiment, a compositioncomprises an iodophor in the range between 0.1% and 5.0%. In anotherembodiment, a composition comprises an iodophor in the range between0.25% and 9.0%. In another embodiment, a composition comprises aniodophor in the range between 0.2% and 2.5%. In another embodiment, acomposition comprises an iodophor in the range between 0.5% and 7.5%. %.In another embodiment, a composition comprises an iodophor in the rangebetween 0.5% and 1.0%. In another embodiment, a composition comprises aniodophor in the range between 0.75% and 5.0%, and in yet anotherembodiment, between 1.0% and 4.0%. In an embodiment, a compositioncomprises an iodophor in the range of about 0.1% to about 2.5%, about0.2% to about 2.0%, about 0.3% to about 1.0%, and about 0.4% to about0.75%.

In an embodiment, a composition comprises elemental iodine in the rangeof about 0.01% to about 15%. In another embodiment, a compositioncomprises elemental iodine in the range between 0.05% and 12.5%. Inanother embodiment, a composition comprises elemental iodine in therange between 0.05% and 10.0%. In another embodiment, a compositioncomprises elemental iodine in the range between 0.1% and 10.0%. Inanother embodiment, a composition comprises elemental iodine in therange between 0.1% and 5.0%. In another embodiment, a compositioncomprises elemental iodine in the range between 0.25% and 9.0%. Inanother embodiment, a composition comprises elemental iodine in therange between 0.2% and 2.5%. In another embodiment, a compositioncomprises elemental iodine in the range between 0.5% and 7.5%. %. Inanother embodiment, a composition comprises elemental iodine in therange between 0.5% and 1.0%. In another embodiment, a compositioncomprises elemental iodine in the range between 0.75% and 5.0%, and inyet another embodiment, between 1.0% and 4.0%. In an embodiment, acomposition comprises elemental iodine in the range of about 0.1% toabout 2.5%, about 0.2% to about 2.0%, about 0.3% to about 1.0%, andabout 0.4% to about 0.75%.

In an embodiment, a composition comprises PVP-I in the range of about0.01% to about 15%. In another embodiment, a composition comprises PVP-Iin the range between 0.05% and 12.5%. In another embodiment, acomposition comprises PVP-I in the range between 0.05% and 10.0%. Inanother embodiment, a composition comprises PVP-I in the range between0.1% and 10.0%. In another embodiment, a composition comprises PVP-I inthe range between 0.1% and 5.0%. In another embodiment, a compositioncomprises PVP-I in the range between 0.25% and 9.0%. In anotherembodiment, a composition comprises PVP-I in the range between 0.2% and2.5%. In another embodiment, a composition comprises PVP-I in the rangebetween 0.5% and 7.5%. %. In another embodiment, a composition comprisesPVP-I in the range between 0.5% and 1.0%. In another embodiment, acomposition comprises PVP-I in the range between 0.75% and 5.0%, and inyet another embodiment, between 1.0% and 4.0%. In an embodiment, acomposition comprises PVP-I in the range of about 0.1% to about 2.5%,about 0.2% to about 2.0%, about 0.3% to about 1.0%, and about 0.4% toabout 0.75%.

In an embodiment, a composition comprises PVP-I at about 0.001%, about0.005%, about 0.01%, about 0.05%, about 0.1%, about 0.2%, about 0.3%,about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%,about 1.0%, about 1.25%, about 1.50%, about 1.75%, about 2.0%, about2.5%, about 5%, about 7.5%, about 10%, about 12.5, or about 15.0%. In anembodiment, a composition comprises PVP-I at 0.001%, 0.005%, 0.01%,0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%,1.25%, 1.5%, 1.75%, 2.0%, 2.25%, 2.5%, 5%, 7.5%, 10.0%, 12.5%, or 15%.In another embodiment, a composition comprises PVP-I at about 1%, about2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about9%, about 10%. In another embodiment, a composition comprises PVP-I atabout 0.1% or less, about 0.5% or less, about 1% or less, about 2% orless, about 3% or less, about 4% or less, about 5% or less, about 6% orless, about 7% or less, about 8% or less, about 9% or less or about 10%or less. In another embodiment, a composition comprises PVP-I at about0.01% or more, about 0.05% or more, about 0.075% or more, about 0.1% ormore, about 0.2% or more, about 0.3% or more, about 0.4% or more, about0.5% or more, about 0.6% or more, about 0.7% or more, about 0.8% ormore, about 0.9% or more, about 1% or more, about 2% or more, about 3%or more, about 4% or more, about 5% or more, about 6% or more, about 7%or more, about 8% or more, about 9% or more or about 10% or more. Inanother embodiment, a composition comprises PVP-I at 0.001%, 0.005%,0.01%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%,1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0% or 10.0%.

In an embodiment, a composition comprises DMSO and PVP-I. In anembodiment, a composition consists essentially of DMSO and PVP-I. In anembodiment, a composition consists of DMSO and PVP-I. In an embodiment,a composition is anhydrous. In an embodiment, a composition issubstantially anhydrous. In an embodiment, a composition comprises ameasurable amount of water.

In an embodiment, anhydrous DMSO is used in a composition. In anembodiment, substantially anhydrous DMSO is used in a composition. Itwill be understood by one of skill in the art that DMSO can be producedand/or obtained in differing grades, and that one of the variables amongDMSO preparations of different grades is the water content. By way ofexample, DMSO may be completely anhydrous (also referred to hereinsimply as “anhydrous”), substantially anhydrous, or may contain water toa measurable degree. It will be understood that the amount of measurablewater in a DMSO preparation may vary based on limitations of theinstrumentation and techniques used to make such measurements. In anembodiment, DMSO that is not completely anhydrous may be substantiallyanhydrous and contain water at a level below levels of detectability. Inan embodiment, DMSO that is not completely anhydrous may contain water,wherein the water content is about at least 0.01%, about at least 0.02%,about at least 0.03%, about at least 0.04%, about at least 0.05%, aboutat least 0.06%, about at least 0.07%, about at least 0.08%, about atleast 0.09%, about at least 0.1%, about at least 0.2%, about at least0.3%, about at least 0.4%, about at least 0.5%, about at least 0.6%,about at least 0.7%, about at least 0.8%, about at least 0.9%, about atleast 1.0%, about at least 1.5%, about at least 2.0%, about at least2.5%, about at least 5%, about at least 7.5%, about at least 10%, aboutat least 12.5%, or greater. In an embodiment, DMSO that is notcompletely anhydrous may contain water, wherein the water content isabout less than 0.01%, about less than 0.02%, about less than 0.03%,about less than 0.04%, about less than 0.05%, about less than 0.06%,about less than 0.07%, about less than 0.08%, about less than 0.09%,about less than 0.1%, about less than 0.2%, about less than 0.3%, aboutless than 0.4%, about less than 0.5%, about less than 0.6%, about lessthan 0.7%, about less than 0.8%, about less than 0.9%, about less than1.0%, about less than 1.5%, about less than 2.0%, about less than 2.5%,about less than 5%, about less than 7.5%, about less than 10%, aboutless than 12.5%, or greater. It will be understood that DMSO may containone or more other impurities in addition to water.

In an embodiment, a composition comprises an iodophor, a penetrant, andfurther comprises water. In an embodiment, a composition comprises ananyhydrous iodophor and/or an anyhydrous penetrant, and furthercomprises water. In an embodiment, a composition comprises PVP-I, DMSO,and further comprises water. In an embodiment, a composition comprisesan iodophor and a penetrant, and further comprises water, wherein thewater content is about at least 0.01%, about at least 0.02%, about atleast 0.03%, about at least 0.04%, about at least 0.05%, about at least0.06%, about at least 0.07%, about at least 0.08%, about at least 0.09%,about at least 0.1%, about at least 0.2%, about at least 0.3%, about atleast 0.4%, about at least 0.5%, about at least 0.6%, about at least0.7%, about at least 0.8%, about at least 0.9%, about at least 1.0%,about at least 1.5%, about at least 2.0%, about at least 2.5%, about atleast 5%, about at least 7.5%, about at least 10%, about at least 12.5%,or greater. In an embodiment, a composition comprises an iodophor and apenetrant, and further comprises water, wherein the water content isabout less than 0.01%, about less than 0.02%, about less than 0.03%,about less than 0.04%, about less than 0.05%, about less than 0.06%,about less than 0.07%, about less than 0.08%, about less than 0.09%,about less than 0.1%, about less than 0.2%, about less than 0.3%, aboutless than 0.4%, about less than 0.5%, about less than 0.6%, about lessthan 0.7%, about less than 0.8%, about less than 0.9%, about less than1.0%, about less than 1.5%, about less than 2.0%, about less than 2.5%,about less than 5%, about less than 7.5%, about less than 10%, aboutless than 12.5%, or greater. In an embodiment, a composition comprisesan iodophor and a penetrant, and further comprises water, wherein thewater content is about 0.01% to about 12.5%, about 0.02% to about 10.0%,about 0.03% to about 7.5%, about 0.04% to about 5%, about 0.05% to about2.5%, about 0.06% to about 2%, about 0.07% to about 1.5%, about 0.08% toabout 1%, about 0.09% to about 0.9%, about 0.1% to about 0.8%, or about0.2% to about 0.7%. In an aspect, the water may be derived from acomponent of the composition. In another aspect, the water may bespecifically added to the composition.

In an embodiment, a composition comprises at least one of United StatesPharmacopeial Convention (USP) grade DMSO, Active PharmaceuticalIngredient (API) grade DMSO, analytical grade DMSO, and AmericanChemical Society (ACS) Spectrophotometric grade DMSO. In an embodiment,a composition comprises DMSO having <0.1% water by KF titrationand >99.9% determined on an anyhdrous basis.

As set forth above, the percent amount of DMSO in a composition isdescribed in a weight-to-weight (w/w) ratio with respect to one or moreother components of the composition, unless otherwise indicated. In anembodiment, the weight percent DMSO is the balance of the weight percentafter addition of PVP-I. By way of a non-limiting example, a compositionmay comprise 1 weight percent (1%) PVP-I and 99 weight percent (99%)DMSO. It will be understood that in the foregoing example, the DMSOcomponent of the composition may be completely anhydrous, substantiallyanhydrous, or may contain water to a measurable degree. In anembodiment, the weight percent DMSO is the balance of the weight percentafter addition of PVP-I and any other components (e.g., co-solvent,water, additional active ingredient, etc. . . . ). In an embodiment, theweight percent DMSO is the balance of the weight percent after additionof iodophor and other components, if any. In an embodiment, the weightpercent penetrant in a composition is the balance of the weight percentafter addition of iodophor and other components, if any.

In an embodiment, a composition comprises DMSO in the range of 50% to99.99%. In an embodiment, a composition comprises DMSO in the range of1% to 99.99%. In another embodiment, a composition comprises DMSO in therange of 5% and 99.9%. In another embodiment, a composition comprisesDMSO in the range of 10% and 99.9%. In another embodiment, a compositioncomprises DMSO in the range of 20% and 99.9%. In another embodiment, acomposition comprises DMSO in the range of 30% and 99.9%. In anotherembodiment, a composition comprises DMSO in the range of 40% and 99.9%.In another embodiment, a composition comprises DMSO in the range of 50%and 99.9%. In another embodiment, a composition comprises DMSO in therange of 60% and 99.9%. In another embodiment, a composition comprisesDMSO in the range of 70% and 99.9%. In another embodiment, a compositioncomprises DMSO in the range of 80% and 99.9%, and in yet anotherembodiment, between 90% and 99.9%. In an embodiment, a compositioncomprises DMSO in weight percent of about at least 80%, about at least85%, about at least 87.5%, about at least 90%, about at least 91%, aboutat least 92%, about at least 93%, about at least 94%, about at least95%, about at least 96%, about at least 97%, about at least 98%, aboutat least 99%, or about at least 99.9%.

In an embodiment, a composition comprises DMSO but does not comprise anyadditional solvent (e.g., co-solvent) or penetrant. In anotherembodiment, a composition comprises DMSO in the range of about 0.01% to99.99% and further comprises at least one co-solvent in the range of0.01% to about 99.99%. In an embodiment, a composition comprises DMSOand further comprises at least one co-solvent in the range of about 0.1%to about 50%. In another embodiment, a composition comprises DMSO andfurther comprises at least one co-solvent in the range between about 5%and about 50%. In another embodiment, a composition comprises DMSO andfurther comprises at least one co-solvent in the range between about 10%and about 99%. In another embodiment, a composition comprises DMSO andfurther comprises at least one co-solvent in the range between about 20%and about 95%. In an embodiment, a composition comprises DMSO andfurther comprises at least one co-solvent in the range of about 50% toabout 60%, about 60% to about 80%, about 70% to about 90%, and about 80%to about 95%. In an aspect, water is a co-solvent. In an embodiment, acomposition comprises DMSO, water, and at least one additionalco-solvent.

In an embodiment, a composition comprises DMSO in the range of about0.01% to 99.99% and further comprises at least one penetrant in therange of 0.01% to about 99.99%. In an embodiment, a compositioncomprises DMSO and further comprises at least one penetrant in the rangeof about 0.1% to about 50%. In another embodiment, a compositioncomprises DMSO and further comprises at least one penetrant in the rangebetween about 5% and about 50%. In another embodiment, a compositioncomprises DMSO and further comprises at least one penetrant in the rangebetween about 10% and about 99%. In an embodiment, a compositioncomprises DMSO, at least one co-solvent, and at least one penetrant. Inan embodiment, a co-solvent is also a penetrant.

In an embodiment, a composition includes at least one antifungal agentselected from the group consisting of tolnaftate, terbinafine,undecylenic acid, clioquinol, miconazole, miconazole nitrate,clorrinazole, tioconazole, nystatin, terconazoic, butoconazole nitrate,ciclopirox olamine, econazole nitrate, triacetin, flucytosine,haloprogin, and ketoconazole. In an embodiment, the at least oneantifungal agent is present of about 0.01%, about 0.05%, about 0.1%,about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%,about 0.8%, about 0.9%, about 1.0%, about 1.25%, about 1.50%, about1.75%, about 2.0%, about 2.5%, about 5%, about 7.5%, about 10%, about12.5, about 15.0%, about 20%, about 25%, about 30%, about 40%, or about50%. In an embodiment, a composition comprises the at least oneantifungal agent of 0.01%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%,0.7%, 0.8%, 0.9%, 1.0%, 1.25%, 1.5%, 1.75%, 2.0%, 2.25%, 2.5%, 5%, 7.5%,10.0%, 12.5%, 15%, 20%, 25%, 30%, 40%, or 50%. In another embodiment, acomposition comprises the at least one antifungal agent of about 0.1% orless, about 0.5% or less, about 1% or less, about 2% or less, about 3%or less, about 4% or less, about 5% or less, about 6% or less, about 7%or less, about 8% or less, about 9% or less, about 10% or less, about20% or less, about 25% or less, about 30% or less, about 40% or less, orabout 50% or less. In another embodiment, a composition comprises the atleast one antifungal agent of about 0.1% or more, about 0.5% or more,about 1% or more, about 2% or more, about 3% or more, about 4% or more,about 5% or more, about 6% or more, about 7% or more, about 8% or more,about 9% or more, about 10% or more, about 20% or more, about 25% ormore, about 30% or more, about 40% or more, or about 50% or more. Inanother embodiment, a composition comprises the at least one antifungalagent of 0.01%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%,0.9%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%, 20%,25%, 30%, 40%, or 50%.

In an embodiment, stable preparations of at least one topicalanti-fungal ingredient known in the art including, by way ofnon-limiting example, 1% tolnaftate, 10-25% undecylenic acid, clioquinol3% and/or miconazole nitrate 2%, can be prepared in DMSO solvent systemswhere PVP-I is also incorporated as a long-term preservative. Thesesolutions demonstrate remarkable long-term stability where both thePVP-I component and the anti-fungal component are able to be maintainedat or above 90% of the initial concentrations. It is surprisingly foundthat no appreciable reaction occurs between the antifungal agent and thePVP-I. These formulations also demonstrate remarkable in vitro and invivo efficacy as antifungal agents.

In an embodiment, where possible, compositions may includepharmaceutically acceptable salts of compounds in the composition. In anembodiment, compositions comprise acid addition salts of the presentcompounds. In an embodiment, compositions comprise base addition saltsof the present compounds. As used herein, the term pharmaceuticallyacceptable salts or complexes refers to salts or complexes (e.g.,solvates, polymorphs) that retain the desired biological activity of theparent compound and exhibit minimal, if any, undesired toxicologicaleffects.

Methods of Preparation and Use

It is known to one of skill in the art that PVP-I aqueous solutions aredifficult to stabilize at low PVP-I concentrations over a long period oftime. By way of a non-limiting example, at concentrations of PVP-I lessthan about 0.7% (w/w, aqueous), PVP-I aqueous solutions rapidly decay toyield complex mixtures of iodinated and iodine-free constituents. Asdescribed herein, it was surprisingly found that in the aprotic DMSOsolvent system encompassed by the disclosure set forth herein, PVP-Isolutions as low as 0.1% can be easily prepared and maintained as stablecompositions for long periods of time. Also as described herein,hydrated DMSO solutions prepared from aqueous PVP-I demonstrateincreased stability is noted for the PVP-I component.

In an embodiment, a composition comprises dry, solid or powdered PVP-Idissolved or suspended in a composition comprising or consisting ofDMSO. In another embodiment, DMSO is added to an aqueous preparationcomprising or consisting of PVP-I. Based on the disclosure herein, oneof skill in the art will understand how to prepare a composition toarrive at the desired amounts of iodine, iodophor, and DMSO, among otherpossible components of the compositions encompassed herein.

By way of a non-limiting example, a therapeutically-effectivepharmaceutical composition is prepared using solid PVP-I, which isdissolved or suspended in DMSO. In an aspect, the composition isanhydrous. In an aspect, the composition is substantially anhydrous. Inanother embodiment, DMSO can be added to aqueous solutions of PVP-I toprepare a therapeutically-effective pharmaceutical composition. In anembodiment, DMSO is used in the range of 50%-99% as a co-solvent withwater. In an embodiment, a formulation includes one or more excipients.By way of a non-limiting example, excipients include, but are notlimited to, sodium chloride, sodium dihydrogen phosphate monohydrate,disodium hydrogen phosphate anhydrous and water, as well as others knownto those skilled in the art.

In an embodiment, a composition is prepared by adding 10% PVP-I (w/v,aqueous) to pure DMSO q.s. to yield a resulting solution of 1% PVP-I(w/w) with DMSO. In another embodiment, compositions are prepared bydissolving solid PVP-I in pure DMSO q.s to obtain any of 0.1%, 0.2%,0.3%, 0.4%, 0.5%, 1.0%, 1.25%, 1.5%, 2.0%, or 2.5% PVP-I (w/w), as wellas about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about1.0%, about 1.25%, about 1.5%, about 2.0%, or about 2.5% PVP-I (w/w)compositions, with DMSO as the solvent. In yet another embodiment,compositions are prepared by dissolving solid PVP-I in pure DMSO q.s toobtain any composition set forth, described, and/or encompassed herein.Similar compositions comprising aqueous PVP-I (with and withoutexcipients commonly used and/or known in the art) and DMSO can beprepared from a stock 10% PVP-I aqueous solution and pure DMSO. It willbe understood by the skilled artisan, however, that any startingcomposition of PVP-I, solid or liquid, may be used when the appropriatedilutions and adjustments are made to result in the desired final PVP-Iconcentration. Similarly, any starting composition of iodophor orelemental iodine may be used when the appropriate dilutions andadjustments are made to result in the desired final iodophor orelemental iodine concentration, respectively.

In an embodiment, it is particularly useful for the case of ungualinfections that stable, anhydrous compositions that contain between0.01%-10% PVP-I can be prepared in pure USP grade DMSO solvents.

It will be understood, based on the disclosure set forth herein, in viewof the skill in the art, that specific dosage for compounds andcompositions encompassed herein may be determined empirically throughclinical and/or pharmacokinetic experimentation, and that such dosagesmay be adjusted according to prespecified effectiveness and/or toxicitycriteria. It will also be understood that a specific dosage andtreatment regimen for any particular patient will depend upon a varietyof factors, including the activity of the specific compounds employed,the characteristics of the patient, drug combination, the judgment ofthe treating physician and the nature and severity of the particulardisease or condition being treated.

In an embodiment, a composition set forth, described, and/or encompassedherein is useful for treating one or more of—but not limitedto—onychomycosis, paronychia, verrucous warts, molluscum contagiosum,non-genital herpes simplex, scars, gram negative toe-web infection,psoriatic nail dystrophy, and tinea pedis. In an embodiment, thecomposition comprises PVP-I and DMSO. In an embodiment, the compositionconsists essentially of PVP-I and DMSO. In an embodiment, thecomposition consists of PVP-I and DMSO.

In an embodiment, a therapeutic composition is prepared by optimizingone or more compounds for use in a dosage form different than that whichis typically used for the compound. In an embodiment, a compound that isnot typically administered in a topical dosage form is developed for usein a topical dosage form. The chemical and biological assays requiredfor such development are known to one of skill in the art. Thedisclosure herein provides the skilled artisan with the guidance as tohow to prepare such compounds and compositions comprising suchcompounds.

In an embodiment, a method of treating a subject having an ungualinfection includes administration of a composition set forth, described,and/or encompassed herein to treat the ungual infection, and thetreatment of the ungual infection includes at least one of preventing orslowing the progression of the infection, preventing the spread of theinfection, eradicating at least some of the infection, and eradicatingthe entire infection.

In an embodiment, a therapeutic composition is administered on aschedule once a day. In an embodiment, a therapeutic composition isadministered twice a day. In an embodiment, a therapeutic composition isadministered three times a day, four times a day, five times a day, ormore. In an embodiment, a therapeutic composition is administered lessfrequently than once a day. In an embodiment, a therapeutic compositionis administered once every two days, once every three days, once everyfour days, once every five days, once every six days, or once everyseven days. In an embodiment, a therapeutic composition is administeredless frequently than once a week. In an embodiment, a therapeuticcomposition is administered once a month. In an embodiment, atherapeutic composition is administered twice a month.

In an embodiment, a therapeutic dosing regimen is continued for at leastone day, at least two days, at least three days, at least four days, atleast five days, at least six days, or at least seven days. In anembodiment, a therapeutic dosing regimen is continued for at least oneweek, at least two weeks, at least three weeks, at least four weeks, atleast six weeks, at least eight weeks, at least ten weeks, at leasttwelve weeks, at least fourteen weeks, or at least sixteen weeks. In anembodiment, a therapeutic dosing regimen is continued for at least onemonth, at least two months, at least three months, at least four months,at least five months, at least six months, at least nine months, or atleast twelve months.

The invention is further described by the following examples. In anaspect, the following examples demonstrate effective and/or successfultreatment of the identified conditions using compositions and methodsencompassed by the present disclosure. It should be recognized thatvariations based on the inventive features are within the skill of theordinary artisan, and that the scope of the invention should not belimited by the examples. To properly determine the scope of theinvention, an interested party should consider the claims herein, andany equivalent thereof. In addition, all citations herein areincorporated by reference, and unless otherwise expressly stated, allpercentages are by weight.

EXAMPLE 1 Distal Subungual Onychomycosis; Treated with 1% PVP-I in 99%USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 25years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 1% PVP-I in 99% USPGrade DMSO with no additional water or alcohols. The patient was treatedby applying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. Within one week improvement wasnoted in the surrounding skin infection. After 2 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate began to separate from the underlying nail bed and was removedwith scissors. The underlying nail bed appeared to be normal and free ofinfection. The new nail began to grow in free of infection in above theuninfected nail bed. After 20 weeks of treatment at least 5 mm of clearnail could be seen growing free of infection.

EXAMPLE 2 Distal Subungual Onychomycosis; Treated with 0.5% PVP-I in99.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 25years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 1% PVP-I in 99.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 2 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with scissors. The underlying nail bed appeared to benormal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 3 Distal Subungual Onychomycosis; Treated with 1.5% PVP-I in98.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 5years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 1.5% PVP-I in 98.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 4 Distal Subungual Onychomycosis; Treated with 2.0% PVP-I in 98%USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 3years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 2.0% PVP-I in 98%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 5 Distal Subungual Onychomycosis; Treated with 2.5% PVP-I in97.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 4years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 2.5% PVP-I in 97.5% USPGrade DMSO with no additional water or alcohols. The patient was treatedby applying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. Within one week improvement wasnoted in the surrounding skin infection. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate began to separate from the underlying nail bed and was removedwith nail clippers. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 6 Distal Subungual Onychomycosis; Treated with 3.0% PVP-I in 97%USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 10years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 3.0% PVP-I in 97% USP GradeDMSO with no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. Within one week improvement wasnoted in the surrounding skin infection. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate began to separate from the underlying nail bed and was removedwith nail clippers. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 7 Distal Subungual Onychomycosis; Treated with 3.5% PVP-I in96.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 2years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 3.5% PVP-I in 96.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 8 Distal Subungual Onychomycosis; Treated with 4.0% PVP-I in 96%USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 2years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 4.0% PVP-I in 96% USP GradeDMSO with no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. Within one week improvement wasnoted in the surrounding skin infection. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate began to separate from the underlying nail bed and was removedwith nail clippers. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 9 Distal Subungual Onychomycosis; Treated with 4.5% PVP-I in95.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 7years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 4.5% PVP-I in 95.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 10 Distal Subungual Onychomycosis; Treated with 5.0% PVP-I in95% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 5years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 5.0% PVP-I in 95%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 11 Distal Subungual Onychomycosis; Treated with 5.5% PVP-I in94.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 4years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 5.5% PVP-I in 94.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 12 Distal Subungual Onychomycosis; Treated with 6.0% PVP-I in94% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 5years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 6.0% PVP-I in 94%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 13 Distal Subungual Onychomycosis; Treated with 6.5% PVP-I in93.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 10years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 6.5% PVP-I in 93.5% USPGrade DMSO with no additional water or alcohols. The patient was treatedby applying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. Within one week improvement wasnoted in the surrounding skin infection. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate began to separate from the underlying nail bed and was removedwith nail clippers. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 14 Distal Subungual Onychomycosis; Treated with 7.0% PVP-I in93% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 3years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 7.0% PVP-I in 93%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 15 Distal Subungual Onychomycosis; Treated with 7.5% PVP-I in92.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 13years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 7.5% PVP-I in 92.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 16 Distal Subungual Onychomycosis; Treated with 8.0% PVP-I in92% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 6years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 8.0% PVP-I in 92%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 17 Distal Subungual Onychomycosis; Treated with 8.5% PVP-I in91.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 6years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 8.5% PVP-I in 91.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 18 Distal Subungual Onychomycosis; Treated with 9.0% PVP-I in91% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 18years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 9.0% PVP-I in 91%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 19 Distal Subungual Onychomycosis; Treated with 9.5% PVP-I in90.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 1year. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 9.5% PVP-I in 90.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 20 Distal Subungual Onychomycosis; Treated with 10.0% PVP-I in90% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from distal subungual onychomycosis. In thismost common type of onychomycosis, the end of the nail plate becomesdiscolored, thickened and often malodorous. Often the periungual skin isaffected. In this patient, the condition had been persistent for over 3years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton metagrophytes.Prepared was a composition as disclosed herein using 10.0% PVP-I in 90%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 21 White Superficial Onychomycosis; Treated with 0.5% PVP-I in99.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from white superficial onychomycosis. This isa less common subtype of onychomycosis in which the fungus only invadesthe most superficial portion of the nail plate and does not invade thenail bed or underlying surface of the nail. The dorsal portion of thenail plate appears chalky white. The surrounding skin is not typicallyaffected. In this patient, the condition had been present for over 2years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 0.5% PVP-I in 99.5% USPGrade DMSO with no additional water or alcohols. The patient was treatedby applying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate changed from chalky white to a normal appearing nail as it grewout from the matrix. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 22 White Superficial Onychomycosis; Treated with 1.0% PVP-I in99% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from white superficial onychomycosis. This isa less common subtype of onychomycosis in which the fungus only invadesthe most superficial portion of the nail plate and does not invade thenail bed or underlying surface of the nail. The dorsal portion of thenail plate appears chalky white. The surrounding skin is not typicallyaffected. In this patient, the condition had been present for over 4years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 1.0% PVP-I in 99% USP GradeDMSO with no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate changed from chalky white to a normal appearing nail as it grewout from the matrix. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 23 White Superficial Onychomycosis; Treated with 1.5% PVP-I in98.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from white superficial onychomycosis. This isa less common subtype of onychomycosis in which the fungus only invadesthe most superficial portion of the nail plate and does not invade thenail bed or underlying surface of the nail. The dorsal portion of thenail plate appears chalky white. The surrounding skin is not typicallyaffected. In this patient, the condition had been present for over 3years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 1.5% PVP-I in 98.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. After 12 weeks oftreatment the cultures were repeated and were found to be negative. Theaffected nail plate changed from chalky white to a normal appearing nailas it grew out from the matrix. The underlying nail bed appeared to benormal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 24 White Superficial Onychomycosis; Treated with 2.0% PVP-I in98% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from white superficial onychomycosis. This isa less common subtype of onychomycosis in which the fungus only invadesthe most superficial portion of the nail plate and does not invade thenail bed or underlying surface of the nail. The dorsal portion of thenail plate appears chalky white. The surrounding skin is not typicallyaffected. In this patient, the condition had been present for over 3years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 2.0% PVP-I in 98% USP GradeDMSO with no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate changed from chalky white to a normal appearing nail as it grewout from the matrix. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 25 White Superficial Onychomycosis; Treated with 2.5% PVP-I in97.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from white superficial onychomycosis. This isa less common subtype of onychomycosis in which the fungus only invadesthe most superficial portion of the nail plate and does not invade thenail bed or underlying surface of the nail. The dorsal portion of thenail plate appears chalky white. The surrounding skin is not typicallyaffected. In this patient, the condition had been present for over 2years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton mentagrophytes.Prepared was a composition as disclosed herein using 2.5% PVP-I in 97.5%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. After 12 weeks oftreatment the cultures were repeated and were found to be negative. Theaffected nail plate changed from chalky white to a normal appearing nailas it grew out from the matrix. The underlying nail bed appeared to benormal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 26 White Superficial Onychomycosis; Treated with 3.0% PVP-I in97% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from white superficial onychomycosis. This isa less common subtype of onychomycosis in which the fungus only invadesthe most superficial portion of the nail plate and does not invade thenail bed or underlying surface of the nail. The dorsal portion of thenail plate appears chalky white. The surrounding skin is not typicallyaffected. In this patient, the condition had been present for over 1year. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 3.0% PVP-I in 97% USP GradeDMSO with no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate changed from chalky white to a normal appearing nail as it grewout from the matrix. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 27 White Superficial Onychomycosis; Treated with 10% PVP-I in90% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from white superficial onychomycosis. This isa less common subtype of onychomycosis in which the fungus only invadesthe most superficial portion of the nail plate and does not invade thenail bed or underlying surface of the nail. The dorsal portion of thenail plate appears chalky white. The surrounding skin is not typicallyaffected. In this patient, the condition had been present for over 2years. The patient had tried numerous prescription and OTC remedies.Pre-treatment cultures were positive for Trycophyton rubrum. Preparedwas a composition as disclosed herein using 10% PVP-I in 90% USP GradeDMSO with no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. After 12 weeks of treatment thecultures were repeated and were found to be negative. The affected nailplate changed from chalky white to a normal appearing nail as it grewout from the matrix. The underlying nail bed appeared to be normal andfree of infection. The new nail began to grow in free of infection inabove the uninfected nail bed. After 20 weeks of treatment at least 5 mmof clear nail could be seen growing free of infection.

EXAMPLE 28 Total Dystrophic Onychomycosis; Treated with 0.5% PVP-I in99.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from total dystrophic onychomycosis. In thismost recalcitrant subtype of onychomycosis, the entire nail platebecomes dystrophic. It demonstrates a severely thickened, discolored,often malodorous infection. Nail matrix involvement and dermatophytomasare frequently present. Commonly the periungual and interdigital skinare affected. In this patient, the condition had been persistent forover 18 years. The patient had tried numerous prescription and OTCremedies. Pre-treatment cultures were positive for Trichophytonmetagrophytes. Prepared was a composition as disclosed herein using 0.5%PVP-I in 99.5% USP Grade DMSO with no additional water or alcohols. Thepatient was treated by applying the solution topically twice each day tothe nail itself and the surrounding skin with a nailbrush. Within oneweek improvement was noted in the surrounding skin infection. After 12weeks of treatment the cultures were repeated and were found to benegative. The affected nail plate began to separate from the underlyingnail bed and was removed with nail clippers. The underlying nail bedappeared to be normal and free of infection. The new nail began to growin free of infection in above the uninfected nail bed. After 20 weeks oftreatment at least 5 mm of clear nail could be seen growing free ofinfection.

EXAMPLE 29 Total Dystrophic Onychomycosis; Treated with 1.0% PVP-I in99% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from total dystrophic onychomycosis. In thismost recalcitrant subtype of onychomycosis, the entire nail platebecomes dystrophic. It demonstrates a severely thickened, discolored,often malodorous infection. Nail matrix involvement and dermatophytomasare frequently present. Commonly the periungual and interdigital skinare affected. In this patient, the condition had been persistent forover 8 years. The patient had tried numerous prescription and OTCremedies. Pre-treatment cultures were positive for Trichophytonmetagrophytes. Prepared was a composition as disclosed herein using 1.0%PVP-I in 99% USP Grade DMSO with no additional water or alcohols. Thepatient was treated by applying the solution topically twice each day tothe nail itself and the surrounding skin with a nailbrush. Within oneweek improvement was noted in the surrounding skin infection. After 12weeks of treatment the cultures were repeated and were found to benegative. The affected nail plate began to separate from the underlyingnail bed and was removed with nail clippers. The underlying nail bedappeared to be normal and free of infection. The new nail began to growin free of infection in above the uninfected nail bed. After 20 weeks oftreatment at least 5 mm of clear nail could be seen growing free ofinfection.

EXAMPLE 30 Total Dystrophic Onychomycosis; Treated with 1.5% PVP-I in98.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from total dystrophic onychomycosis. In thismost recalcitrant subtype of onychomycosis, the entire nail platebecomes dystrophic. It demonstrates a severely thickened, discolored,often malodorous infection. Nail matrix involvement and dermatophytomasare frequently present. Commonly the periungual and interdigital skinare affected. In this patient, the condition had been persistent forover 3 years. The patient had tried numerous prescription and OTCremedies. Pre-treatment cultures were positive for Trichophytonmetagrophytes. Prepared was a composition as disclosed herein using 1.5%PVP-I in 98.5% USP Grade DMSO with no additional water or alcohols. Thepatient was treated by applying the solution topically twice each day tothe nail itself and the surrounding skin with a nailbrush. Within oneweek improvement was noted in the surrounding skin infection. After 12weeks of treatment the cultures were repeated and were found to benegative. The affected nail plate began to separate from the underlyingnail bed and was removed with nail clippers. The underlying nail bedappeared to be normal and free of infection. The new nail began to growin free of infection in above the uninfected nail bed. After 20 weeks oftreatment at least 5 mm of clear nail could be seen growing free ofinfection.

EXAMPLE 31 Total Dystrophic Onychomycosis; Treated with 2.0% PVP-I in98% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from total dystrophic onychomycosis. In thismost recalcitrant subtype of onychomycosis, the entire nail platebecomes dystrophic. It demonstrates a severely thickened, discolored,often malodorous infection. Nail matrix involvement and dermatophytomasare frequently present. Commonly the periungual and interdigital skinare affected. In this patient, the condition had been persistent forover 4 years. The patient had tried numerous prescription and OTCremedies. Pre-treatment cultures were positive for Trichophyton rubrum.Prepared was a composition as disclosed herein using 2.0% PVP-I in 98%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to the nailitself and the surrounding skin with a nailbrush. Within one weekimprovement was noted in the surrounding skin infection. After 12 weeksof treatment the cultures were repeated and were found to be negative.The affected nail plate began to separate from the underlying nail bedand was removed with nail clippers. The underlying nail bed appeared tobe normal and free of infection. The new nail began to grow in free ofinfection in above the uninfected nail bed. After 20 weeks of treatmentat least 5 mm of clear nail could be seen growing free of infection.

EXAMPLE 32 Total Dystrophic Onychomycosis; Treated with 2.5% PVP-I in97.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from total dystrophic onychomycosis. In thismost recalcitrant subtype of onychomycosis, the entire nail platebecomes dystrophic. It demonstrates a severely thickened, discolored,often malodorous infection. Nail matrix involvement and dermatophytomasare frequently present. Commonly the periungual and interdigital skinare affected. In this patient, the condition had been persistent forover 2 years. The patient had tried numerous prescription and OTCremedies. Pre-treatment cultures were positive for Trichophytonmetagrophytes. Prepared was a composition as disclosed herein using 2.5%PVP-I in 99% USP Grade DMSO with no additional water or alcohols. Thepatient was treated by applying the solution topically twice each day tothe nail itself and the surrounding skin with a nailbrush. Within oneweek improvement was noted in the surrounding skin infection. After 12weeks of treatment the cultures were repeated and were found to benegative. The affected nail plate began to separate from the underlyingnail bed and was removed with nail clippers. The underlying nail bedappeared to be normal and free of infection. The new nail began to growin free of infection in above the uninfected nail bed. After 20 weeks oftreatment at least 5 mm of clear nail could be seen growing free ofinfection.

EXAMPLE 33 Paronychia; treated with 0.5% PVP-I in 99.5% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from paronychia secondary to treatment withEpidermal Growth Factor Receptor Inhibitors for Lung Cancer. Thecondition often affects both finger and toenails and can bedebilitating, necessitating discontinuation of the treatment regimen. Itis characterized by erythematous, painful, swollen and sometimesfluctuant proximal nails folds caused by a mixed infection involvingbacteria, yeast, and fungi. Chronic inflammation of this area can leadto scarring of the nail matrix, leading to nail deformity. In thispatient, the condition had been persistent for over 2 years. The patienthad tried numerous prescription and OTC remedies. Pre-treatment cultureswere positive for bacteria and yeast. Prepared was a composition asdisclosed herein using 0.5% PVP-I in 99.5% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the nail itself and the surroundingskin with a nailbrush. Within one week dramatic improvement was noted inthe proximal nail fold. After 4 weeks of treatment the cultures wererepeated and were found to be negative. The affected nail plate began togrow in normally. After 12 weeks of treatment the proximal nail foldappeared normal without discomfort. 5 mm of new, healthy nail could beseen growing in without dystrophy.

EXAMPLE 34 Paronychia; Treated with 1.0% PVP-I in 99% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from paronychia secondary to treatment withEpidermal Growth Factor Receptor Inhibitors for Lung Cancer. Thecondition often affects both finger and toenails and can bedebilitating, necessitating discontinuation of the treatment regimen. Itis characterized by erythematous, painful, swollen and sometimesfluctuant proximal nails folds caused by a mixed infection involvingbacteria, yeast, and fungi. Chronic inflammation of this area can leadto scarring of the nail matrix, leading to nail deformity. In thispatient, the condition had been persistent for over 1 year. The patienthad tried numerous prescription and OTC remedies. Pre-treatment cultureswere positive for bacteria and yeast. Prepared was a composition asdisclosed herein using 1.0% PVP-I in 99% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the nail itself and the surroundingskin with a nailbrush. Within one week dramatic improvement was noted inthe proximal nail fold. After 4 weeks of treatment the cultures wererepeated and were found to be negative. The affected nail plate began togrow in normally. After 12 weeks of treatment the proximal nail foldappeared normal without discomfort. 5 mm of new, healthy nail could beseen growing in without dystrophy.

EXAMPLE 35 Paronychia; Treated with 1.5% PVP-I in 98.5% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from paronychia secondary to treatment withEpidermal Growth Factor Receptor Inhibitors for Lung Cancer. Thecondition often affects both finger and toenails and can bedebilitating, necessitating discontinuation of the treatment regimen. Itis characterized by erythematous, painful, swollen and sometimesfluctuant proximal nails folds caused by a mixed infection involvingbacteria, yeast, and fungi. Chronic inflammation of this area can leadto scarring of the nail matrix, leading to nail deformity. In thispatient, the condition had been persistent for over 6 months. Thepatient had tried numerous prescription and OTC remedies. Pre-treatmentcultures were positive for bacteria and yeast. Prepared was acomposition as disclosed herein using 1.5% PVP-I in 98.5% USP Grade DMSOwith no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the nail itself andthe surrounding skin with a nailbrush. Within one week dramaticimprovement was noted in the proximal nail fold. After 4 weeks oftreatment the cultures were repeated and were found to be negative. Theaffected nail plate began to grow in normally. After 12 weeks oftreatment the proximal nail fold appeared normal without discomfort. 5mm of new, healthy nail could be seen growing in without dystrophy.

EXAMPLE 36 Paronychia; Treated with 2.0% PVP-I in 98% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from paronychia secondary to treatment withEpidermal Growth Factor Receptor Inhibitors for Lung Cancer. Thecondition often affects both finger and toenails and can bedebilitating, necessitating discontinuation of the treatment regimen. Itis characterized by erythematous, painful, swollen and sometimesfluctuant proximal nails folds caused by a mixed infection involvingbacteria, yeast, and fungi. Chronic inflammation of this area can leadto scarring of the nail matrix, leading to nail deformity. In thispatient, the condition had been persistent for over 2 years. The patienthad tried numerous prescription and OTC remedies. Pre-treatment cultureswere positive for bacteria and yeast. Prepared was a composition asdisclosed herein using 2.0% PVP-I in 99% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the nail itself and the surroundingskin with a nailbrush. Within one week dramatic improvement was noted inthe proximal nail fold. After 4 weeks of treatment the cultures wererepeated and were found to be negative. The affected nail plate began togrow in normally. After 12 weeks of treatment the proximal nail foldappeared normal without discomfort. 5 mm of new, healthy nail could beseen growing in without dystrophy.

EXAMPLE 37 Paronychia; Treated with 2.5% PVP-I in 97.5% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from paronychia secondary to treatment withEpidermal Growth Factor Receptor Inhibitors for Liver Cancer. Thecondition often affects both finger and toenails and can bedebilitating, necessitating discontinuation of the treatment regimen. Itis characterized by erythematous, painful, swollen and sometimesfluctuant proximal nails folds caused by a mixed infection involvingbacteria, yeast, and fungi. Chronic inflammation of this area can leadto scarring of the nail matrix, leading to nail deformity. In thispatient, the condition had been persistent for over 1 year. The patienthad tried numerous prescription and OTC remedies. Pre-treatment cultureswere positive for bacteria and yeast. Prepared was a composition asdisclosed herein using 2.5% PVP-I in 99% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the nail itself and the surroundingskin with a nailbrush. Within one week dramatic improvement was noted inthe proximal nail fold. After 4 weeks of treatment the cultures wererepeated and were found to be negative. The affected nail plate began togrow in normally. After 12 weeks of treatment the proximal nail foldappeared normal without discomfort. 5 mm of new, healthy nail could beseen growing in without dystrophy.

EXAMPLE 38 Non-Genital Verruca Vulgaris; Treated with 0.5% PVP-I in99.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from non-genital verruca vulgaris (warts) ofthe soles of both feet. Warts in this anatomical area are extremelydifficult to treat, as they often grow quite deep into the skin and havemany layers of thick skin protecting them from topical treatments. Thecondition is often very painful with walking or running and commontreatments such as Liquid Nitrogen destruction often result insignificant downtime for the patient. Warts are often spread and becomelarger from chronic friction in the area. In this patient, the conditionhad been persistent for over 1 year. The patient had tried numerousprescription and OTC remedies. Prepared was a composition as disclosedherein using 0.5% PVP-I in 99% USP Grade DMSO with no additional wateror alcohols. The patient was treated by applying the solution topicallytwice each day to the wart itself with a nailbrush. Within four weeksthe warts decreased in diameter by 50%, and after 8 weeks of treatmentthe wart was completely resolved.

EXAMPLE 39 Non-Genital Verruca Vulgaris; Treated with 1.0% PVP-I in 99%USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from non-genital verruca vulgaris (warts) ofthe soles of both feet and hands. Warts in this anatomical area areextremely difficult to treat, as they often grow quite deep into theskin and have many layers of thick skin protecting them from topicaltreatments. The condition is often very painful with walking or runningand common treatments such as Liquid Nitrogen destruction often resultin significant downtime for the patient. The condition is also sociallyembarrassing for patients. Warts are often spread and become larger fromchronic friction in the area. In this patient, the condition had beenpersistent for over 2 years. The patient had tried numerous prescriptionand OTC remedies. Prepared was a composition as disclosed herein using1.0% PVP-I in 99% USP Grade DMSO with no additional water or alcohols.The patient was treated by applying the solution topically twice eachday to the wart itself with a nailbrush. Within four weeks the wartsdecreased in diameter by 50%, and after 12 weeks of treatment the wartwas completely resolved.

EXAMPLE 40 Non-Genital Verruca Vulgaris; Treated with 1.5% PVP-I in98.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from non-genital verruca vulgaris (warts) ofthe soles of both feet. Warts in this anatomical area are extremelydifficult to treat, as they often grow quite deep into the skin and havemany layers of thick skin protecting them from topical treatments. Thecondition is often very painful with walking or running and commontreatments such as Liquid Nitrogen destruction often result insignificant downtime for the patient. The condition is also sociallyembarrassing for patients. Warts are often spread and become larger fromchronic friction in the area. In this patient, the condition had beenpersistent for over 4 years. The patient had tried numerous prescriptionand OTC remedies. Prepared was a composition as disclosed herein using1.5% PVP-I in 99% USP Grade DMSO with no additional water or alcohols.The patient was treated by applying the solution topically twice eachday to the wart itself with a nailbrush. Within four weeks the wartsdecreased in diameter by 50%, and after 8 weeks of treatment the wartwas completely resolved.

EXAMPLE 41 Non-Genital Verruca Vulgaris; Treated with 2.5% PVP-I in97.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from non-genital verruca vulgaris (warts) ofthe palms of both hands. Warts in this anatomical area are extremelydifficult to treat, as they often grow quite deep into the skin and havemany layers of thick skin protecting them from topical treatments. Thecondition is often very painful with use of hands for daily tasks andcommon treatments such as Liquid Nitrogen destruction often result insignificant downtime for the patient. The condition is also sociallyembarrassing for patients. Warts are often spread and become larger fromchronic friction in the area. In this patient, the condition had beenpersistent for over 6 months. The patient had tried numerousprescription and OTC remedies. Prepared was a composition as disclosedherein using 2.5% PVP-I in 97.5% USP Grade DMSO with no additional wateror alcohols. The patient was treated by applying the solution topicallytwice each day to the wart itself with a nailbrush. Within four weeksthe warts decreased in diameter by 50%, and after 12 weeks of treatmentthe wart was completely resolved.

EXAMPLE 42 Non-Genital Verruca Vulgaris; Treated with 3.0% PVP-I in 97%USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from non-genital verruca vulgaris (warts) ofknees. Warts in this anatomical area are extremely difficult to treat,as they often grow quite deep into the skin and have many layers ofthick skin protecting them from topical treatments. The condition isoften very painful with walking or running and common treatments such asLiquid Nitrogen destruction often result in significant downtime for thepatient. The condition is also socially embarrassing for patients. Wartsare often spread and become larger from chronic friction in the area. Inthis patient, the condition had been persistent for over 2 years. Thepatient had tried numerous prescription and OTC remedies. Prepared was acomposition as disclosed herein using 3.0% PVP-I in 99% USP Grade DMSOwith no additional water or alcohols. The patient was treated byapplying the solution topically twice each day to the wart itself with anailbrush. Within four weeks the warts decreased in diameter by 50%, andafter 12 weeks of treatment the wart was completely resolved.

EXAMPLE 43 Non-Genital Verruca Vulgaris; Treated with 1.0% PVP-I in 40%USP Grade DMSO with Polyethylene Glycol

This patient was suffering from non-genital verruca vulgaris (warts) ofthe soles of both feet. Warts in this anatomical area are extremelydifficult to treat, as they often grow quite deep into the skin and havemany layers of thick skin protecting them from topical treatments. Thecondition is often very painful with walking or running and commontreatments such as Liquid Nitrogen destruction often result insignificant downtime for the patient. The condition is also sociallyembarrassing for patients. Warts are often spread and become larger fromchronic friction in the area. In this patient, the condition had beenpersistent for over 6 months. The patient had tried numerousprescription and OTC remedies. Prepared was a composition as disclosedherein using 1.0% PVP-I in 40% USP Grade DMSO with polyethylene glycol.The patient was treated by applying the solution topically twice eachday to the wart itself with a nailbrush. Within four weeks the wartsdecreased in diameter by 50%, and after 8 weeks of treatment the wartwas completely resolved.

EXAMPLE 44 Non-Genital Verruca Vulgaris; Treated with 1.5% PVP-I in 40%USP Grade DMSO with Polyethylene Glycol

This patient was suffering from non-genital verruca vulgaris (warts) ofthe sole of one foot. Warts in this anatomical area are extremelydifficult to treat, as they often grow quite deep into the skin and havemany layers of thick skin protecting them from topical treatments. Thecondition is often very painful with walking or running and commontreatments such as Liquid Nitrogen destruction often result insignificant downtime for the patient. The condition is also sociallyembarrassing for patients. Warts are often spread and become larger fromchronic friction in the area. In this patient, the condition had beenpersistent for over 6 months. The patient had tried numerousprescription and OTC remedies. Prepared was a composition as disclosedherein using 1.5% PVP-I in 40% USP Grade DMSO with polyethylene glycol.The patient was treated by applying the solution topically twice eachday to the wart itself with a nailbrush. Within four weeks the wartsdecreased in diameter by 50%, and after 12 weeks of treatment the wartwas completely resolved.

EXAMPLE 45 Non-Genital Verruca Vulgaris; Treated with 2.0% PVP-I in 40%USP Grade DMSO with Polyethylene Glycol

This patient was suffering from non-genital verruca vulgaris (warts) ofthe palms of both hands. Warts in this anatomical area are extremelydifficult to treat, as they often grow quite deep into the skin and havemany layers of thick skin protecting them from topical treatments. Thecondition is often very painful with daily activities and commontreatments such as Liquid Nitrogen destruction often result insignificant downtime for the patient. The condition is also sociallyembarrassing for patients. Warts are often spread and become larger fromchronic friction in the area. In this patient, the condition had beenpersistent for over 1 year. The patient had tried numerous prescriptionand OTC remedies. Prepared was a composition as disclosed herein using2.0% PVP-I in 40% USP Grade DMSO with polyethylene glycol. The patientwas treated by applying the solution topically twice each day to thewart itself with a nailbrush. Within four weeks the warts decreased indiameter by 50%, and after 8 weeks of treatment the wart was completelyresolved.

EXAMPLE 46 Molluscum Contagiosum; Treated with 0.5% PVP-I in 99.5% USPGrade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from molluscum contagiousum on the trunk.This condition is caused by a viral infection that is easily spread bytouch. It affects children most commonly, but adults are not excluded.It presents as small, skin colored umbilicated papules. They can becomeirritated and painful. They also can become secondarily infected withbacteria. Common treatment methods can take months to work at home, orinvolved painful procedures for children to tolerate in the officesetting. In this patient, the condition had been persistent for 3months. The patient had tried numerous prescription and OTC remedies.Prepared was a composition as disclosed herein using 0.5% PVP-I in 99%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice each day to themolluscum with a nailbrush. Within 2 weeks the lesions had resolvedcompletely.

EXAMPLE 47 Molluscum Contagiosum; Treated with 1.0% PVP-I in 99% USPGrade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from molluscum contagiousum on the buttocks.This condition is caused by a viral infection that is easily spread bytouch. It affects children most commonly, but adults are not excluded.It presents as small, skin colored umbilicated papules. They can becomeirritated and painful. They also can become secondarily infected withbacteria. Common treatment methods can take months to work at home, orinvolved painful procedures for children to tolerate in the officesetting. In this patient, the condition had been persistent for 6 monthsand was spreading rapidly. The patient had tried numerous prescriptionand OTC remedies. Prepared was a composition as disclosed herein using1.0% PVP-I in 99% USP Grade DMSO with no additional water or alcohols.The patient was treated by applying the solution topically twice eachday to the molluscum with a nailbrush. Within 2 weeks the lesions hadresolved completely.

EXAMPLE 48 Molluscum Contagiosum; Treated with 1.5% PVP-I in 98.5% USPGrade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from molluscum contagiousum on the neck andback. This condition is caused by a viral infection that is easilyspread by touch. It affects children most commonly, but adults are notexcluded. It presents as small, skin colored umbilicated papules. Theycan become irritated and painful. They also can become secondarilyinfected with bacteria. Common treatment methods can take months to workat home, or involved painful procedures for children to tolerate in theoffice setting. In this patient, the condition had been persistent for 2months. The patient had tried numerous prescription and OTC remedies.Prepared was a composition as disclosed herein using 1.5% PVP-I in 99%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice daily to the molluscumwith a nailbrush. Within 2 weeks the lesions had resolved completely.

EXAMPLE 49 Molluscum Contagiosum; Treated with 2.0% PVP-I in 98% USPGrade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from molluscum contagiousum on the elbows andforearms. This condition is caused by a viral infection that is easilyspread by touch. It affects children most commonly, but adults are notexcluded. It presents as small, skin colored umbilicated papules. Theycan become irritated and painful. They also can become secondarilyinfected with bacteria. Common treatment methods can take months to workat home, or involved painful procedures for children to tolerate in theoffice setting. In this patient, the condition had been persistent for 5months. The patient had tried numerous prescription and OTC remedies.Prepared was a composition as disclosed herein using 2.0% PVP-I in 99%USP Grade DMSO with no additional water or alcohols. The patient wastreated by applying the solution topically twice daily to the molluscumwith a nailbrush. Within 3 weeks the lesions had resolved completely.

EXAMPLE 50 Gram Negative Toeweb Infection; Treated with 1.0% PVP-I in99% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from gram-negative toe web infection. Thistype of infection often happens in the immunocompromised population. Itpresents are an eroded, macerated, erythematous plaque in theinterdigital spaces on the volar surface of the foot. It is oftenmalodorous and painful, inhibiting the ability of the patient to walk.Gram-negative bacteria are the causative agents, and in this case theculture grew Pseudomonas aureginosa. In this patient, the condition hadbeen persistent for over 2 months. The patient had tried numerousprescription and OTC remedies with temporary improvement but consistentrelapses. Prepared was a composition as disclosed herein using 1.0%PVP-I in 99% USP Grade DMSO with no additional water or alcohols. Thepatient was treated by applying the solution topically twice each day tothe infected and painful skin with a nailbrush. Within one day the painsignificantly improved, and in 5 days the infection completely cleared.Cultures were negative at one week and the infection did not return.

EXAMPLE 51 Gram Negative Toeweb Infection; Treated with 2.5% PVP-I in97.5% USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from gram-negative toe web infection. Thistype of infection often happens in the immunocompromised population. Itpresents are an eroded, macerated, erythematous plaque in theinterdigital spaces on the volar surface of the foot. It is oftenmalodorous and painful, inhibiting the ability of the patient to walk.Gram-negative bacteria are the causative agents, and in this case theculture grew Pseudomonas aeruginosa. In this patient, the condition hadbeen persistent for over 4 months. The patient had tried numerousprescription and OTC remedies with temporary improvement but consistentrelapses. Prepared was a composition as disclosed herein using 2.5%PVP-I in 99% USP Grade DMSO with no additional water or alcohols. Thepatient was treated by applying the solution topically twice each day tothe infected and painful skin with a nailbrush. Within three days thepain significantly improved, and in 6 days the infection completelycleared. Cultures were negative at one week and the infection did notreturn.

EXAMPLE 52 Non-Genital Herpes Simplex Virus; Treated with 1.0% PVP-I in40% USP Grade DMSO in Hydrophilic Base with No Additional Water orAlcohol or Co-Solvents

This patient was suffering from non-genital herpes simplex virus (commoncold sore). In this most common type of infection, after contraction viaphysical contact with an infected person the virus lays dormant in thedorsal root ganglia of nerves distributed in the oral area. With aprecipitating stressor the inciting immunosuppression the virusreplicates and causes the common cold sore. The lesions can be quitelarge and painful, sometimes making eating and drinking veryuncomfortable. The lesions are often socially stigmatizing and causeembarrassment on the part of the patient. Cold sores are caused mostcommonly by Herpes Simplex Virus 1 and they last on average 2 weeks.Some patients have frequent (>6) outbreaks per years. The patient hadtried numerous prescription and OTC remedies but complained that none ofthem worked very quickly. Prepared was a composition as disclosed hereinusing 1.0% PVP-I in 40% USP Grade DMSO in a hydrophilic base with noadditional water or alcohols. The patient was treated by applying theointment topically twice each day to cold sore and immediately adjacentskin. Within 1 day the lesion began to shrink and pain was alleviatedcompletely. Within 3 days the lesion was crusted over and at 5 days thelesion was completely resolved.

EXAMPLE 53 Non-Genital Herpes Simplex Virus; Treated with 1.5% PVP-I in40% USP Grade DMSO in Hydrophilic Base with No Additional Water orAlcohol or Co-Solvents

This patient was suffering from non-genital herpes simplex virus (commoncold sore). In this most common type of infection, after contraction viaphysical contact with an infected person the virus lays dormant in thedorsal root ganglia of nerves distributed in the oral area. With aprecipitating stressor the inciting immunosuppression the virusreplicates and causes the common cold sore. The lesions can be quitelarge and painful, sometimes making eating and drinking veryuncomfortable. The lesions are often socially stigmatizing and causeembarrassment on the part of the patient. Cold sores are caused mostcommonly by Herpes Simplex Virus 1 and they last on average 2-3 weeks.Some patients have frequent (>6) outbreaks per years. The patient hadtried numerous prescription and OTC remedies but complained that none ofthem worked very quickly. Prepared was a composition as disclosed hereinusing 1.5% PVP-I in 40% USP Grade DMSO in a hydrophilic base with noadditional water or alcohols. The patient was treated by applying theointment topically twice each day to cold sore and immediately adjacentskin. Within 1 day the lesion began to shrink and pain was alleviatedcompletely. Within 3 days the lesion was crusted over and at 7 days thelesion was completely resolved.

EXAMPLE 54 Non-Genital Herpes Simplex Virus; Treated with 2.0% PVP-I in40% USP Grade DMSO in Hydrophilic Base with No Additional Water orAlcohol or Co-Solvents

This patient was suffering from non-genital herpes simplex virus (commoncold sore). In this most common type of infection, after contraction viaphysical contact with an infected person the virus lays dormant in thedorsal root ganglia of nerves distributed in the oral area. With aprecipitating stressor the inciting immunosuppression the virusreplicates and causes the common cold sore. The lesions can be quitelarge and painful, sometimes making eating and drinking veryuncomfortable. The lesions are often socially stigmatizing and causeembarrassment on the part of the patient. Cold sores are caused mostcommonly by Herpes Simplex Virus 1 and they last on average 2-3 weeks.Some patients have frequent (>6) outbreaks per years. The patient hadtried numerous prescription and OTC remedies but complained that none ofthem worked very quickly. Prepared was a composition as disclosed hereinusing 2.0% PVP-I in 40% USP Grade DMSO in a hydrophilic base with noadditional water or alcohols. The patient was treated by applying theointment topically twice each day to cold sore and immediately adjacentskin. Within 2 days the lesion began to shrink and pain was alleviatedcompletely. Within 3 days the lesion was crusted over and at 6 days thelesion was completely resolved.

EXAMPLE 55 Non-Genital Herpes Simplex Virus; Treated with 1.0% PVP-I in45% USP Grade DMSO in Hydrophilic Base with No Additional Water orAlcohol or Co-Solvents

This patient was suffering from non-genital herpes simplex virus (commoncold sore). In this most common type of infection, after contraction viaphysical contact with an infected person the virus lays dormant in thedorsal root ganglia of nerves distributed in the oral area. With aprecipitating stressor the inciting immunosuppression the virusreplicates and causes the common cold sore. The lesions can be quitelarge and painful, sometimes making eating and drinking veryuncomfortable. The lesions are often socially stigmatizing and causeembarrassment on the part of the patient. Cold sores are caused mostcommonly by Herpes Simplex Virus 1 and they last on average 2-3 weeks.Some patients have frequent (>6) outbreaks per years. The patient hadtried numerous prescription and OTC remedies but complained that none ofthem worked very quickly. Prepared was a composition as disclosed hereinusing 1.0% PVP-I in 45% USP Grade DMSO in a hydrophilic base with noadditional water or alcohols. The patient was treated by applying theointment topically twice each day to cold sore and immediately adjacentskin. Within 3 days the lesion began to shrink and pain was alleviatedcompletely. Within 5 days the lesion was crusted over and at 7 days thelesion was completely resolved.

EXAMPLE 56 Non-Genital Herpes Simplex Virus; Treated with 2.0% PVP-I in45% USP Grade DMSO in Hydrophilic Base with No Additional Water orAlcohol or Co-Solvents

This patient was suffering from non-genital herpes simplex virus (commoncold sore). In this most common type of infection, after contraction viaphysical contact with an infected person the virus lays dormant in thedorsal root ganglia of nerves distributed in the oral area. With aprecipitating stressor the inciting immunosuppression the virusreplicates and causes the common cold sore. The lesions can be quitelarge and painful, sometimes making eating and drinking veryuncomfortable. The lesions are often socially stigmatizing and causeembarrassment on the part of the patient. Cold sores are caused mostcommonly by Herpes Simplex Virus 1 and they last on average 2-3 weeks.Some patients have frequent (>6) outbreaks per years. The patient hadtried numerous prescription and OTC remedies but complained that none ofthem worked very quickly. Prepared was a composition as disclosed hereinusing 2.0% PVP-I in 45% USP Grade DMSO in a hydrophilic base with noadditional water or alcohols. The patient was treated by applying theointment topically twice each day to cold sore and immediately adjacentskin. Within 1 day the lesion began to shrink and pain was alleviatedcompletely. Within 3 days the lesion was crusted over and at 6 days thelesion was completely resolved.

EXAMPLE 57 Non-Genital Herpes Simplex Virus; Treated with 2.0% PVP-I in50% USP Grade DMSO in Hydrophilic Base with No Additional Water orAlcohol or Co-Solvents

This patient was suffering from non-genital herpes simplex virus (commoncold sore). In this most common type of infection, after contraction viaphysical contact with an infected person the virus lays dormant in thedorsal root ganglia of nerves distributed in the oral area. With aprecipitating stressor the inciting immunosuppression the virusreplicates and causes the common cold sore. The lesions can be quitelarge and painful, sometimes making eating and drinking veryuncomfortable. The lesions are often socially stigmatizing and causeembarrassment on the part of the patient. Cold sores are caused mostcommonly by Herpes Simplex Virus 1 and they last on average 2-3 weeks.Some patients have frequent (>6) outbreaks per years. The patient hadtried numerous prescription and OTC remedies but complained that none ofthem worked very quickly. Prepared was a composition as disclosed hereinusing 2.0% PVP-I in 50% USP Grade DMSO in a hydrophilic base with noadditional water or alcohols. The patient was treated by applying theointment topically twice each day to cold sore and immediately adjacentskin. Within 2 days the lesion began to shrink and pain was alleviatedcompletely. Within 5 days the lesion was crusted over and at 8 days thelesion was completely resolved.

EXAMPLE 58 Non-Genital Herpes Simplex Virus; Treated with 1.0% PVP-I in50% USP Grade DMSO in Hydrophilic Base with No Additional Water orAlcohol or Co-Solvents

This patient was suffering from non-genital herpes simplex virus (commoncold sore). In this most common type of infection, after contraction viaphysical contact with an infected person the virus lays dormant in thedorsal root ganglia of nerves distributed in the oral area. With aprecipitating stressor the inciting immunosuppression the virusreplicates and causes the common cold sore. The lesions can be quitelarge and painful, sometimes making eating and drinking veryuncomfortable. The lesions are often socially stigmatizing and causeembarrassment on the part of the patient. Cold sores are caused mostcommonly by Herpes Simplex Virus 1 and they last on average 2-3 weeks.Some patients have frequent (>6) outbreaks per years. The patient hadtried numerous prescription and OTC remedies but complained that none ofthem worked very quickly. Prepared was a composition as disclosed hereinusing 1.0% PVP-I in 50% USP Grade DMSO in a hydrophilic base with noadditional water or alcohols. The patient was treated by applying theointment topically twice each day to cold sore and immediately adjacentskin. Within 2 days the lesion began to shrink and pain was alleviatedcompletely. Within 4 days the lesion was crusted over and at 7 days thelesion was completely resolved.

EXAMPLE 59 Post Operative Excision Sites; Treated with 1.0% PVP-I in 40%USP Grade DMSO in Hydrophilic Base with No Additional Water or Alcoholor Co-Solvents

This patient had a skin cancer excised and the wound was sutured closed.This can often lead to tenderness and pain at the site, along with therisk of the procedure leaving a cosmetically unacceptable scar. Typicalwound care involves cleaning the area thoroughly daily, along withapplying antibiotic ointment or petrolatum in order to prevent andinfection and keep the wound moist. It is well known in Dermatology thatmoist wound heal much better than wounds permitted to dry and crustover. Prepared was a composition as disclosed herein using 1.0% PVP-I in40% USP Grade DMSO in a hydrophilic base with no additional water oralcohols. The patient was treated by applying the ointment topicallytwice daily to the wound and immediately adjacent skin. The patientdenied any tenderness associated with the procedure. The wound healedvery well and was quite acceptable to the patient. There was no evidenceof postoperative wound infection. The patient was seen at follow-up of 6weeks and the scar continued to heal well.

EXAMPLE 60 Post Operative Excision Sites; Treated with 2.0% PVP-I in 40%USP Grade DMSO in Hydrophilic Base with No Additional Water or Alcoholor Co-Solvents

This patient had a skin cancer excised and the wound was sutured closed.This can often lead to tenderness and pain at the site, along with therisk of the procedure leaving a cosmetically unacceptable scar. Typicalwound care involves cleaning the area thoroughly daily, along withapplying antibiotic ointment or petrolatum in order to prevent andinfection and keep the wound moist. It is well known in Dermatology thatmoist wound heal much better than wounds permitted to dry and crustover. Prepared was a composition as disclosed herein using 2.0% PVP-I in40% USP Grade DMSO in a hydrophilic base with no additional water oralcohols. The patient was treated by applying the ointment topicallytwice daily to the wound and immediately adjacent skin. The patientdenied any tenderness associated with the procedure. The wound healedvery well and was quite acceptable to the patient. There was no evidenceof postoperative wound infection. The patient was seen at follow-up of 6weeks and the scar continued to heal well.

EXAMPLE 61 Post Operative Excision Sites; Treated with 1.0% PVP-I in 45%USP Grade DMSO in Hydrophilic Base with No Additional Water or Alcoholor Co-Solvents

This patient had a skin cancer excised and the wound was sutured closed.This can often lead to tenderness and pain at the site, along with therisk of the procedure leaving a cosmetically unacceptable scar. Typicalwound care involves cleaning the area thoroughly daily, along withapplying antibiotic ointment or petrolatum in order to prevent andinfection and keep the wound moist. It is well known in Dermatology thatmoist wound heal much better than wounds permitted to dry and crustover. Prepared was a composition as disclosed herein using 1.0% PVP-I in45% USP Grade DMSO in a hydrophilic base with no additional water oralcohols. The patient was treated by applying the ointment topicallytwice daily to the wound and immediately adjacent skin. The patientdenied any tenderness associated with the procedure. The wound healedvery well and was quite acceptable to the patient. There was no evidenceof postoperative wound infection. The patient was seen at follow-up of 6weeks and the scar continued to heal well.

EXAMPLE 62 Post Operative Excision Sites; Treated with 2.0% PVP-I in 40%USP Grade DMSO in Hydrophilic Base with No Additional Water or Alcoholor Co-Solvents

This patient had a skin cancer excised and the wound was sutured closed.This can often lead to tenderness and pain at the site, along with therisk of the procedure leaving a cosmetically unacceptable scar. Typicalwound care involves cleaning the area thoroughly daily, along withapplying antibiotic ointment or petrolatum in order to prevent andinfection and keep the wound moist. It is well known in Dermatology thatmoist wound heal much better than wounds permitted to dry and crustover. Prepared was a composition as disclosed herein using 2.0% PVP-I in45% USP Grade DMSO in a hydrophilic base with no additional water oralcohols. The patient was treated by applying the ointment topicallytwice daily to the wound and immediately adjacent skin. The patientdenied any tenderness associated with the procedure. The wound healedvery well and was quite acceptable to the patient. There was no evidenceof postoperative wound infection. The patient was seen at follow-up of 6weeks and the scar continued to heal well.

EXAMPLE 63 Post Operative Excision Sites; Treated with 1.0% PVP-I in 50%USP Grade DMSO in Hydrophilic Base with No Additional Water or Alcoholor Co-Solvents

This patient had a skin cancer excised and the wound was sutured closed.This can often lead to tenderness and pain at the site, along with therisk of the procedure leaving a cosmetically unacceptable scar. Typicalwound care involves cleaning the area thoroughly daily, along withapplying antibiotic ointment or petrolatum in order to prevent andinfection and keep the wound moist. It is well known in Dermatology thatmoist wound heal much better than wounds permitted to dry and crustover. Prepared was a composition as disclosed herein using 1.0% PVP-I in50% USP Grade DMSO in a hydrophilic base with no additional water oralcohols. The patient was treated by applying the ointment topicallytwice daily to the wound and immediately adjacent skin. The patientdenied any tenderness associated with the procedure. The wound healedvery well and was quite acceptable to the patient. There was no evidenceof postoperative wound infection. The patient was seen at follow-up of 6weeks and the scar continued to heal well.

EXAMPLE 64 Post Operative Excision Sites; Treated with 2.0% PVP-I in 50%USP Grade DMSO in Hydrophilic Base with No Additional Water or Alcoholor Co-Solvents

This patient had a skin cancer excised and the wound was sutured closed.This can often lead to tenderness and pain at the site, along with therisk of the procedure leaving a cosmetically unacceptable scar. Typicalwound care involves cleaning the area thoroughly daily, along withapplying antibiotic ointment or petrolatum in order to prevent andinfection and keep the wound moist. It is well known in Dermatology thatmoist wound heal much better than wounds permitted to dry and crustover. Prepared was a composition as disclosed herein using 2.0% PVP-I in50% USP Grade DMSO in a hydrophilic base with no additional water oralcohols. The patient was treated by applying the ointment topicallytwice daily to the wound and immediately adjacent skin. The patientdenied any tenderness associated with the procedure. The wound healedvery well and was quite acceptable to the patient. There was no evidenceof postoperative wound infection. The patient was seen at follow-up of 6weeks and the scar continued to heal well.

EXAMPLE 65 Tinea Pedis; Treated with 0.5% PVP-I in 99.5% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from tinea pedis. This common type of fungalinfections involves the feet, and often accompanies onychomycosis. Theskin of the interdigital web spaces becomes macerated and cracked, andoften malodorous. Patients often complain of burning and itching. Theentire sole of the foot may become involved. In this patient, thecondition had been persistent for over 3 years. The patient had triednumerous prescription and OTC remedies. Pre-treatment cultures werepositive for Trycophyton metagrophytes. Prepared was a composition asdisclosed herein using 0.5% PVP-I in 99% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the involved skin with a nailbrush.Within 2 days the patient noted much improvement in the symptoms. At oneweek the infection was completely resolved. The patient was cultured at2 weeks after beginning treatment and cultures were negative.

EXAMPLE 66 Tinea Pedis; Treated with 1.0% PVP-I in 99% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from tinea pedis. This common type of fungalinfections involves the feet, and often accompanies onychomycosis. Theskin of the interdigital web spaces becomes macerated and cracked, andoften malodorous. Patients often complain of burning and itching. Theentire sole of the foot may become involved. In this patient, thecondition had been persistent for over 2 years. The patient had triednumerous prescription and OTC remedies. Pre-treatment cultures werepositive for Trycophyton rubrum. Prepared was a composition as disclosedherein using 1.0% PVP-I in 99% USP Grade DMSO with no additional wateror alcohols. The patient was treated by applying the solution topicallytwice each day to the involved skin with a nailbrush. Within 3 days thepatient noted much improvement in the symptoms. At one week theinfection was completely resolved. The patient was cultured at 2 weeksafter beginning treatment and cultures were negative.

EXAMPLE 67 Tinea Pedis; Treated with 1.5% PVP-I in 98.5% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from tinea pedis. This common type of fungalinfections involves the feet, and often accompanies onychomycosis. Theskin of the interdigital web spaces becomes macerated and cracked, andoften malodorous. Patients often complain of burning and itching. Theentire sole of the foot may become involved. In this patient, thecondition had been persistent for over 10 years. The patient had triednumerous prescription and OTC remedies. Pre-treatment cultures werepositive for Trycophyton metagrophytes. Prepared was a composition asdisclosed herein using 1.5% PVP-I in 98.5% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the involved skin with a nailbrush.Within 6 days the patient noted much improvement in the symptoms. At 2weeks the infection was completely resolved. The patient was cultured at2 weeks after beginning treatment and cultures were negative.

EXAMPLE 68 Tinea Pedis; Treated with 2.0% PVP-I in 98% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from tinea pedis. This common type of fungalinfections involves the feet, and often accompanies onychomycosis. Theskin of the interdigital web spaces becomes macerated and cracked, andoften malodorous. Patients often complain of burning and itching. Theentire sole of the foot may become involved. In this patient, thecondition had been persistent for over 5 years. The patient had triednumerous prescription and OTC remedies. Pre-treatment cultures werepositive for Trycophyton metagrophytes. Prepared was a composition asdisclosed herein using 2.0% PVP-I in 98% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the involved skin with a nailbrush.Within 2 days the patient noted much improvement in the symptoms. At 10days the infection was completely resolved. The patient was cultured at2 weeks after beginning treatment and cultures were negative.

EXAMPLE 69 Tinea pedis; Treated with 10.0% PVP-I in 99% USP Grade DMSOwith No Additional Water or Alcohol or Co-Solvents

This patient was suffering from tinea pedis. This common type of fungalinfections involves the feet, and often accompanies onychomycosis. Theskin of the interdigital web spaces becomes macerated and cracked, andoften malodorous. Patients often complain of burning and itching. Theentire sole of the foot may become involved. In this patient, thecondition had been persistent for over 6 years. The patient had triednumerous prescription and OTC remedies. Pre-treatment cultures werepositive for Trycophyton metagrophytes. Prepared was a composition asdisclosed herein using 10.0% PVP-I in 99% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the involved skin with a nailbrush.Within 4 days the patient noted much improvement in the symptoms. At 8days the infection was completely resolved. The patient was cultured at2 weeks after beginning treatment and cultures were negative.

EXAMPLE 70 Psoriatic Nail Disease; Treated with 1.0% PVP-I in 99% USPGrade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from psoriasis involving the nails. Psoriasisis common inflammatory condition that can affect the skin, nails, andjoints. When nail involvement is present, it can be debilitating for thepatient. It can involve finger and toenails and can become quitepainful. It is also socially stigmatizing as nails can become completelydisfigured. Within the nail unit itself, psoriasis can affect thematrix, nail bed or nail plate. It clinically can present as total naildystrophy, pitting or ridging of the nails. In this patient, thecondition had been persistent for over 3 years. The patient had triednumerous prescription and OTC remedies. Prepared was a composition asdisclosed herein using 1.0% PVP-I in 99% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the involved nail and proximal nailfold. Within 4 weeks the patient noted healthy, normal appearing nailgrowing in from the base of the nail. At 12 weeks, she demonstrated 5 mmof normal growth from the base. She continues with therapy to date andcontinues to maintain clear nails.

EXAMPLE 71 Psoriatic Nail Disease; Treated with 2.0% PVP-I in 98% USPGrade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from psoriasis involving the nails. Psoriasisis common inflammatory condition that can affect the skin, nails, andjoints. When nail involvement is present, it can be debilitating for thepatient. It can involve finger and toenails and can become quitepainful. It is also socially stigmatizing as nails can become completelydisfigured. Within the nail unit itself, psoriasis can affect thematrix, nail bed or nail plate. It clinically can present as total naildystrophy, pitting or ridging of the nails. In this patient, thecondition had been persistent for over 12 years. The patient had triednumerous prescription and OTC remedies. Prepared was a composition asdisclosed herein using 2.0% PVP-I in 98% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the involved nail and proximal nailfold. Within 6 weeks the patient noted healthy, normal appearing nailgrowing in from the base of the nail. At 12 weeks, he demonstrated 5 mmof normal growth from the base. He continues with therapy to date andcontinues to maintain clear nails.

EXAMPLE 72 Psoriatic Nail Disease; Treated with 0.5% PVP-I in 99.5% USPGrade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from psoriasis involving the nails. Psoriasisis common inflammatory condition that can affect the skin, nails, andjoints. When nail involvement is present, it can be debilitating for thepatient. It can involve finger and toenails and can become quitepainful. It is also socially stigmatizing as nails can become completelydisfigured. Within the nail unit itself, psoriasis can affect thematrix, nail bed or nail plate. It clinically can present as total naildystrophy, pitting or ridging of the nails. In this patient, thecondition had been persistent for over 5 years. The patient had triednumerous prescription and OTC remedies. Prepared was a composition asdisclosed herein using 0.5% PVP-I in 99.5% USP Grade DMSO with noadditional water or alcohols. The patient was treated by applying thesolution topically twice each day to the involved nail and proximal nailfold. Within 4 weeks the patient noted healthy, normal appearing nailgrowing in from the base of the nail. At 12 weeks, she demonstrated 5 mmof normal growth from the base. She continues with therapy to date andcontinues to maintain clear nails.

EXAMPLE 73 Effect of Anhydrous 1% PVP-I for Treatment of Onychomycosis

Thirteen patients with fungal culture-positive onychomycosis presentedto the practice at the Bryn Mawr Skin and Cancer Institute over a3-month period and were prescribed topical PVP-I, 1% anhydrous solutionin DMSO, as clinically indicated. Patients applied the solution twicedaily to the affected nail folds, subungual space and nail plate for 12weeks. Responses were recorded by clinical examination findings,patient-reported symptoms and fungal culture (Mycosel™ agar) results.

Five (5) men and eight (8) women with a median age of 57 (range 31-71)were evaluated. Patient demographic, clinical and mycological data aredetailed in Table 1.

Previous Culture Week Discoloration Pain Burning Itch Patient Age GenderTreatment 0/12 Pre/Post Pre/Post Pre/Post Pre/Post  01* 53 F Laser, +/+5/4 0/0 0/0 0/0 Lamisil, OTC 02 49 F OTC +/− 3/2 1/1 0/0 1/0 03 47 FNone +/− 4/3 1/0 1/0 1/1 04 71 F OTC +/− 4/2 0/0 0/0 1/1 05 62 F None+/− 4/3 2/1 2/1 2/0 06 36 F Rx Lacquer +/− 5/4 0/0 0/0 1/0  07* 67 FLamisil, OTC +/− 5/3 3/1 0/0 2/1 08 57 M OTC +/− 3/1 0/0 0/0 2/1 09 60 FRx Lacquer +/− 4/2 0/0 0/0 0/0  10* 65 M Lamisil, +/+ 5/3 4/0 3/1 3/0 RxLacquer  11* 67 M Lamisil, +/− 4/1 1/0 0/0 0/0 Rx Lacquer 12 33 M OTC+/− 1/0 0/0 0/0 0/0 13 31 M None +/− 4/2 0/0 0/0 1/0 *Indicates thepresence of dermatophytoma (mass of fungal hyphae present within thenail represented by a thick yellow streak in the nail). For the numerialscores above, patients were asked to assign a numerical value for eachof the subjective categories listed in the table, with 0 indicatingcomplete lack of the symptoms and 5 indicating severe involvement. ForDiscoloration, patients graded the color of nail with the followingpoint scale: 0 - clear, 1 - white, 2 - yellow/white, 3 - yellow, 4 -green, 5 - green/black.

Ten (10) out of thirteen (13) had prior topical and/or oral treatments(range=1-3; median=1). At 12 weeks, 11/13 patients (85%) had negativefungal cultures (compared to positive baseline cultures) and alldemonstrated clinical improvement as assessed by nail discoloration(Figure 1 and Table 1). The 2 patients with positive fungal cultures at12 weeks were 2/4 patients (Table 1—#1,7,10,11) to have had clinicallysevere infections including dermatophytoma (mass of fungal hyphae withinthe nail plate represented by a thick yellow streak). Of the 10/13patients who reported pre-treatment symptoms (pain, burning, pruritus),all 10 (100%) reported symptom improvement by 12 weeks (Table 1). Nopatients discontinued use of PVP-I 1% anhydrous solution due tointolerance and there were no reported adverse reactions.

It is shown here for the first time that treatment with thiswell-tolerated formulation of topical PVP-I, 1% anhydrous solution inDMSO, appears to eradicate fungal organisms from within the nail itself,rendering it an effective treatment for onychomycosis and suggestingpotential benefit in paronychia. The preliminary results of this caseseries appears to address the above issue of nail plate reinfection. All13 patients demonstrated positive fungal cultures prior to initiation oftreatment and at 12 weeks, 11/13 patients (85%) had negative cultureresults. Four (4) patients manifested dermatophytomas. This nail signidentifies a recalcitrant subset since current therapies do noteffectively access the fungal hyphae masses occupying the nail plate. Ofnote, 2/4 patients (50%) with dermatophytomas converted to negativefungal cultures at 12 weeks which suggests that the PVP-I 1% anhydroussolution has the potential ability to rapidly penetrate and eradicatefungal foci in nails. Though the current study did not directly assessthe treatment effect on Pseudomonas, the results support an efficacy inthis common co-morbid infection as well.

EXAMPLE 74 Mature Hypertrophic Scars; Treated with 1.0% PVP-I in 40% USPGrade DMSO in Hydrophilic Base with No Additional Water or Alcohol orCo-Solvents

This patient had a 6 month-old scar after a C-Section procedure wasperformed and the wound was stapled closed. This procedure often leadsto an elevated, film pink cosmetically unacceptable scar that can betender or pruritic. Certain areas of the body are much more prone todeveloping hypertrophic scars, and the lower abdomen is one of thosesites. It is well known in Dermatology that hypertrophic scars are verydifficult to treat and tend to be recalcitrant to treatment. Injectionswith steroids are potential treatment options, but do not come withoutrisk. Much research has been dedicated to studying the pathophysiologybehind scar formation, but still little is understood at this point. Aformulation of 1.0% PVP-I in 40% USP Grade DMSO in a hydrophilic basewith no additional water or alcohols was prepared. The patient wastreated by applying the formulation topically twice daily to thehypertrophic scar. The patient denied any tenderness or irruptionassociated with the procedure. The patient was seen at 6 weeks and 10weeks after beginning use, and noted significant decrease in thepruritis. The appearance of the scar, softened and flattened, and theerythematous color of the skin faded.

EXAMPLE 75 Mature Hypertrophic Scars; Treated with 1.0% PVP-I in 30% USPGrade DMSO in Hydrophilic Base with No Additional Water or Alcohol orCo-Solvents

This patient had a 5 month-old scar after a Mohs procedure was performedand the wound was sutured closed via a transposition flap. Thisprocedure can lead to an elevated, firm pink cosmetically unacceptablescar that can be tender or pruritic. Certain areas of the body are muchmore prone to developing hypertrophic scars, and the nasofacial junctionis one of those sites. It is well known in Dermatology that hypertrophicscars are very difficult to treat and tend to be recalcitrant totreatment. Injections with steroids are potential treatment options, butdo not come without risk. Much research has been dedicated to studyingthe pathophysiology behind scar formation, but still little isunderstood at this point. A formulation of 01.0% PVP-I in 30% USP GradeDMSO in a hydrophilic base with no additional water or alcohols wasprepared. The patient was treated by applying the formulation topicallytwice daily to the hypertrophic scar. The patient denied any tendernessor irruption associated with the procedure. The patient was seen at the4 weeks and 8 weeks after beginning use, and noted significant decreasein the pruritis. The scar softened and flattened, and the erythematouscolor of the skin faded.

EXAMPLE 76 Mature Hypertrophic Scars; Treated with 1.5% PVP-I in 40% USPGrade DMSO in Hydrophilic Base with No Additional Water or Alcohol orCo-Solvents

This patient had a 3 month-old scar after a cosmetic procedure wasperformed for the removal of benign melanocytic nevi on the face and thewounds were sutured closed. This procedure can lead to an elevated, firmpink cosmetically unacceptable scar that can be tender or pruritic.Certain areas of the body are much more prone to developing hypertrophicscars, and the forehead and cheek are amongst those sites. It is wellknown in Dermatology that hypertrophic scars are very difficult to treatand tend to be recalcitrant to treatment. Injections with steroids andlaser therapy are potential treatment options, but do not come withoutrisk. Much research has been dedicated to studying the pathophysiologybehind scar formation, but still little is understood at this point. Aformulation of 1.5% PVP-I in 40% USP Grade DMSO in a hydrophilic basewith no additional water or alcohols was prepared. The patient wastreated by applying the formulation topically twice daily to thehypertrophic scar. The patient denied any tenderness or irruptionassociated with the procedure. The patient was seen at the 4 weeks and10 weeks after beginning use, and noted significant decrease in thepruritis. The scar softened and flattened, and the erythematous color ofthe skin faded.

EXAMPLE 77 Mature Keloid Scar; Treated with 1.0% PVP-I in 40% USP GradeDMSO in Hydrophilic Base with No Additional Water or Alcohol orCo-Solvents

This patient had a 3 month-old scar after a wide excision was performedto remove a Malignant Melanoma and the wound was sutured closed. Thisprocedure can lead to an elevated, firm pink cosmetically unacceptablescar that can be tender or pruritic. Certain areas of the body are muchmore prone to developing hypertrophic scars, and the back is a verycommon site. It is well known in Dermatology that keloid scars are verydifficult to treat and tend to be recalcitrant to treatment. Injectionswith steroids and laser therapy are potential treatment options, but donot come without risk. Much research has been dedicated to studying thepathophysiology behind scar formation, but still little is understood atthis point. A formulation of 1.0% PVP-I in 40% USP Grade DMSO in ahydrophilic base with no additional water or alcohols was prepared. Thepatient was treated by applying the formulation topically twice daily tothe keloid scar. The patient denied any tenderness or irruptionassociated with the procedure. The patient was seen at the 4 weeks, 8weeks, and 12 weeks after beginning use, and noted significant decreasein the pruritis. The scar softened and flattened, and the erythematouscolor of the skin faded.

EXAMPLE 78 Mature Keloid Scar; Treated with 1.0% PVP-I in 50% USP GradeDMSO in Hydrophilic Base with No Additional Water or Alcohol orCo-Solvents

This patient had a 7 month-old scar after a wide excision was performedto remove a Malignant Melanoma and the wound was sutured closed. Thisprocedure can lead to an elevated, firm pink cosmetically unacceptablescar that can be tender or pruritic. Certain areas of the body are muchmore prone to developing hypertrophic scars, and the upper arm is one ofthese sites. It is well known in Dermatology that keloid scars are verydifficult to treat and tend to be recalcitrant to treatment. Injectionswith steroids and laser therapy are potential treatment options, but donot come without risk. Much research has been dedicated to studying thepathophysiology behind scar formation, but still little is understood atthis point. A formulation of 1.0% PVP-I in 50% USP Grade DMSO in ahydrophilic base with no additional water or alcohols was prepared. Thepatient was treated by applying the formulation topically twice daily tothe keloid scar. The patient denied any tenderness or irruptionassociated with the procedure. The patient was seen at the 4 weeks, 8weeks, and 16 weeks after beginning use, and noted significant decreasein the pruritis. The scar softened and flattened, and the erythematouscolor of the skin faded.

EXAMPLE 79 Lichen Planus nail disease; Treated with 1.0% PVP-I in 99%USP Grade DMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering from Lichen Planus involving the nails.Lichen Planus is an uncommon condition that can affect the skin, mucosalmembranes, hand and nails. Nail involvement is rare, but can bedebilitating. The condition affects the nail matrix, leading to dorsalpteryigium of the nail, along with severe scarring, chronic nailshedding and pain from affected nail folds. It can involve finger andtoenails and can become quite painful. It is also socially stigmatizingas nails can become completely disfigured. In this patient, thecondition had been persistent for over 10 years. The patient had seen 10Dermatologists that failed to correctly identify the condition. She hadtried numerous prescription and OTC remedies. A formulation of 1.0%PVP-I in 99% USP Grade DMSO with no additional water or alcohols wasprepared. The patient was treated by applying the formulation topicallytwice each day to the involved nail and proximal nail fold. Within 4weeks the patient noted the inflammation associated with the nail matrixhad greatly subsided and the pain had significantly improved. At 8 weeksshe noted new, normal appearing nails growing in several of herfingernails. At 12 weeks, 2 of her nails were clear and returning to anormal appearing nail.

EXAMPLE 80 Arthropod Assault; Treated with 1.0% PVP-I in 99% USP GradeDMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering numerous arthropod assaults, more commonlyknown as bug bites. Numerous species of insects bite the skin, rangingfrom mosquitos to bees and flies. This is a common occurrence and oftenresults in extremely pruritic raised erythematous papules and plaques.Depending upon an individuals' unique response to a bite, the reactioncan last anywhere from a few minutes to weeks. A formulation of 1.0%PVP-I in 99% USP Grade DMSO with no additional water or alcohols wasprepared. The patient applied the formulation immediately afterrecognizing the bite as being pruritic. The symptoms of itching and thelesion that typically followed was completely eliminated and no furtherapplication was needed.

EXAMPLE 81 Arthropod Assault; Treated with 0.5% PVP-I in 99.5% USP GradeDMSO with No Additional Water or Alcohol or Co-Solvents

This patient was suffering numerous arthropod assaults, more commonlyknown as bug bites. Numerous species of insects bite the skin, rangingfrom mosquitos to bees and flies. This is a common occurrence and oftenresults in extremely pruritic raised erythematous papules and plaques.Depending upon an individuals' unique response to a bite, the reactionand lesions that ensue can last anywhere from a few minutes to weeks. Aformulation of 0.5% PVP-I in 99.5% USP Grade DMSO with no additionalwater or alcohols was prepared. The patient applied the formulation theday following the bites after the lesion had appeared. She utilized theformulation a total of 3 times with complete disappearance of thelesions within one day.

It will be appreciated by those skilled in the art that changes could bemade to the exemplary embodiments shown and described above withoutdeparting from the broad inventive concept thereof. It is understood,therefore, that the disclosure herein is not limited to the exemplaryembodiments shown and described, but it is intended to covermodifications within the spirit and scope of the present invention asdefined by the claims. For example, specific features of the exemplaryembodiments may or may not be part of the claimed invention and featuresof the disclosed embodiments may be combined. Unless specifically setforth herein, the terms “a”, “an” and “the” are not limited to oneelement but instead should be read as meaning “at least one”.

It is to be understood that at least some of the descriptions of theinvention have been simplified to focus on elements that are relevantfor a clear understanding of the invention, while eliminating, forpurposes of clarity, other elements that those of ordinary skill in theart will appreciate may also comprise a portion of the invention.However, because such elements are well known in the art, and becausethey do not necessarily facilitate a better understanding of theinvention, a description of such elements is not provided herein.

Further, to the extent that the method does not rely on the particularorder of steps set forth herein, the particular order of the stepsshould not be construed as limitation on the claims. The claims directedto the method of the present invention should not be limited to theperformance of their steps in the order written, and one skilled in theart can readily appreciate that the steps may be varied and still remainwithin the spirit and scope of the present invention.

What is claimed is:
 1. A topical dermatological composition for treatingan ungual infection, the composition consisting of: (a) povidone-iodine(PVP-I); and (b) greater than 30% dimethylsulfoxide (DMSO).
 2. Thecomposition of claim 1, wherein the composition is substantiallyanhydrous.
 3. The composition of claim 1, wherein the composition isanhydrous.
 4. The composition of claim 1, wherein the PVP-I is presentat about 0.01% to about 10% (w/w).
 5. The composition of claim 1,wherein PVP-I is present in a range selected from the group consistingof about 0.05% to about 10%, about 0.1% to about 5%, about 0.2% to about2.5%, and about 0.5% to about 1% (w/w).
 6. The composition of claim 1,wherein PVP-I is present in a range selected from the group consistingof about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about1.0%, about 1.25%, about 1.5%, about 2.0%, about 2.5%, and about 5%(w/w).
 7. The composition of claim 1, wherein PVP-I is present at about1% (w/w).
 8. A method for treating an ungual infection, comprising: (a)contacting at least one of an infected nail and a non-ungual tissueadjacent to a nail with a composition of claim 1; and (b) repeating thecontacting step as necessary until the ungual infection has beentreated.
 9. The method of claim 8, wherein the contacting step isconducted at least once a day.
 10. The method of claim 9, wherein thecontacting step is conducted at least twice a day.
 11. A method fortreating an ungual infection, comprising: (a) contacting at least one ofan infected nail and a non-ungual tissue adjacent to a nail with acomposition of claim 1; and (b) repeating the contacting step for atleast four weeks.
 12. The method of claim 11, wherein the contactingstep is repeated for at least 12 weeks.
 13. A method for treatingonychomycosis, comprising: (a) contacting at least one of an infectednail and a non-ungual tissue adjacent to a nail with a composition ofclaim 1; and (b) repeating the contacting step for at least four weeks.14. A method for treating onychomycosis, comprising: (a) contacting atleast one of an infected nail and a non-ungual tissue adjacent to a nailwith a composition of claim 1; and (b) repeating the contacting step forat least four weeks.
 15. A method for treating an infection of a nail,comprising: (a) contacting at least one of an infected nail and anon-ungual tissue adjacent to a nail with a composition of claim 1; and(b) repeating the contacting step for at least four weeks, wherein theinfection is caused by at least one of the members selected from thegroup consisting of Trichophyton rubrum, T. mentagrophytes,Epidermophyton floccosum, T. violaceum, Microsporum gypseum, T.tonsurans, T. soudanense, T. verrucosum, and members of Candida spp.,Neoscytalidium spp., Scopulariopsisspp., and Aspergillus spp.
 16. Apharmaceutical composition for treating an ungual infection, thecomposition consisting of: (a) an iodophor; (b) greater than 30%dimethylsulfoxide (DMSO); and (c) at least one pharmaceuticallyacceptable co-solvent which is not a polyglycol, wherein the compositionis capable of penetrating the unguis to treat the infection.
 17. Thecomposition of claim 1, wherein the DMSO is greater than 30% to about50% (w/w) of the composition.
 18. The composition of claim 1, whereinthe DMSO is about 40% to about 50% (w/w) of the composition.
 19. Thecomposition of claim 1, wherein the DMSO is about 40% to about 45% (w/w)of the composition.
 20. The method of claim 8, wherein the infection isa fungal infection.
 21. The method of claim 8, wherein the infection isa dermatophyte infection.
 22. The method of claim 8, wherein theinfection is paronychia.
 23. A topical dermatological composition fortreating an ungual infection, the composition consisting of: (a)pharmaceutically acceptable povidone-iodine; (b) greater than 30%dimethylsulfoxide (DMSO); and (c) at least one co-solvent.
 24. Thecomposition of claim 23, wherein the co-solvent is selected from thegroup consisting of ethyl acetate, acetone, acetonitrile,tetrahydrofuran, methylene chloride, dimethyl formamide, and apolyglycol.
 25. The composition of claim 23 wherein the co-solvent ispolyethylene glycol.
 26. A topical dermatological composition fortreating an ungual infection, the composition consisting of: (a)pharmaceutically acceptable povidone-iodine; (b) greater than 30%dimethylsulfoxide (DMSO); (c) a lubricant; and (d) at least oneco-solvent.
 27. The composition of claim 26, wherein the co-solvent isselected from the group consisting of ethyl acetate, acetone,acetonitrile, tetrahydrofuran, methylene chloride, dimethyl formamide,and a polyglycol.
 28. The composition of claim 26 wherein the co-solventis polyethylene glycol.